1.
ChiCTR; 2023-11-09; TrialID: ChiCTR2300077459
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2300077459
RESUMEN
Condition:
Infantile herpanginaIntervention:
Western medicine control group:Human recombinant interferon alpha 2 b sprays;Acupuncture group:Stab winding bleeding;Primary outcome:
Clinical curative effect;Clinical symptom relief time (including time for herpes to dissipate, time for sore throat to disappear, time for fever to subside, time for appetite improvement, time for salivation to disappear, etc.);Total duration of disease;Criteria:
Inclusion criteria: 1. Meets the diagnostic criteria for pediatric herpetic pharyngitis in Western medicine.2. Age 1-7 years old.
3. The course of the disease is less than 3 days.
4. The nucleic acid test of novel coronavirus pneumonia was negative.
5. The guardian has informed consent, the child cooperates with treatment, and signs an informed consent form.
Exclusion criteria: 1. Patients with concomitant heart, liver, and kidney dysfunction, impaired coagulation mechanisms, and complications.
2. Individuals who are allergic to Western medicine in this study.
3. Needle sickness.
4. Patients with skin inflammation or damage at acupoints.
5. Children with herpes on their hands and feet, or diagnosed with hand, foot, and mouth disease.
6. Individuals with spontaneous bleeding or coagulation disorders.
2.
CTRI; 09-11-2023; TrialID: CTRI/2023/11/059727
Clinical Trial Register
| ICTRP | ID: ictrp-CTRI202311059727
RESUMEN
Condition:
Health Condition 1: N189- Chronic kidney disease, unspecifiedIntervention:
Intervention1: Desidustat: Duration of Therapy: 6 MonthsDesidustat (Oxemia™) is an orally bioavailable, small molecule, hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor developed by Zydus Cadila for the treatment of anaemia associated with chronic kidney disease (CKD), COVID-2019 infections and chemotherapy induced anaemia. Desidustat inhibits prolyl hydroxylase domain enzymes, resulting in the stabilisation of hypoxia-inducible factor which stimulates erythropoietin production and erythropoiesis. In March 2022, desidustat received its first approval in India for the treatment of anaemia in adults with CKD who are either on dialysis or not on dialysis. Desidustat is in clinical development in China for the treatment of anaemia in patients with CKD, in Mexico for the management of COVID-2019 infections and in the USA for the treatment of chemotherapy induced anaemia.
Control Intervention1: Darbepoetin Alfa: Duration of Therapy: 6 Months
Darbepoetin alfa is a medication used to treat anemia due to chronic kidney disease and anemia due to chemotherapy. It is an erythropoiesis-stimulating agent (ESA) that stimulates the bone marrow to produce more red blood cells. Common side effects of Darbepoetin alfa include high blood pressure, rash, injection site pain, breathlessness, cough, peripheral edema, procedural hypotension (low blood pressure), convulsion, and thromboembolism.
Primary outcome:
Mean change in hemoglobinTimepoint: 0 to 6 monthsCriteria:
Inclusion criteria: 1. Current clinical diagnosis of anemia due to CKD, baseline hemoglobin concentrations was to be 7.0-10.0 g/dL (both inclusive) before the enrollment.2. Ability to understand and give informed consent for participation.
3. Male or female patients diagnosed with CKD (stage III to IV), defined by estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.
4. Male or female, 18 to 80 years of age.
5. Body weight > 40 kg.
6. Subjects not on dialysis and not expected to start dialysis during the study period.
7. Serum ferritin =100 ng/mL and/or TSAT >20%.
8. No iron, folate or Vitamin B12 deficiency.
Exclusion criteria: Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
Intravenous iron within 14 days prior to enrollment.
Prior exposure of rhEPO analogues less than 04 weeks.
Red blood cell transfusion within 8 weeks prior to enrollment.
History of previous or concurrent cancer.
Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus infection.
Active infection prior to enrollment.
History of renal transplant.
Major surgery within 90 days of the first day of study drug dosing, and minor surgery within 30 days of the first day of study drug dosing.
Presence or a history of bleeding disorders or clinical conditions that could increase risk of life-threatening bleeding.
Pregnant and breastfeeding women.
3.
ClinicalTrials.gov; 08/11/2023; TrialID: NCT06124625
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06124625
RESUMEN
Condition:
Post-COVID-19 SyndromeIntervention:
Procedure: Rehabilitation + maintenance program;Procedure: Rehabilitation onlyPrimary outcome:
Change from baseline quality of life assessed by Short-Form 12 questionnaire at week 4 and week 19Criteria:
Inclusion Criteria:
- Post-COVID-syndrome (Definition WHO)
- Entered the rehabilitation process at the Schoen Klinik Berchtesgadener Land
Exclusion Criteria:
- No internet access
4.
ClinicalTrials.gov; 08/11/2023; TrialID: NCT06124638
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06124638
RESUMEN
Condition:
COVID-19;Influenza A;Influenza Type BIntervention:
Diagnostic Test: Panbio™ COVID-19/Flu A&B PanelPrimary outcome:
Sensitivity and specificity of the Panbio™ COVID-19/Flu A&B Rapid Panel deviceCriteria:
Inclusion Criteria:
- Participant is at least two (2) years of age, and
- Participant is suspected of acute viral respiratory infection by a healthcare
professional, and
- Participant is within seven (7) days of symptom onset, and
- Participant is experiencing two or more of the following symptoms
- Fever of >100.0°F/ 37.8°C
- Cough
- Fatigue
- New loss of taste or smell
- Congestion or runny nose
- Shortness of breath or difficulty breathing
- Sore throat
- Muscle or body aches
- Headache
- Nausea or vomiting
- Diarrhea
Exclusion Criteria:
- Participant is currently enrolled in a study to evaluate an investigational drug or
experimental treatment
- Participants with an active nosebleed
- Participant has undergone a nasal wash or nasal aspirate procedure on day of enrolment
- Participant has received a nasal spray or mist Influenza vaccine (i.e. FluMist) within
the last 30 days
- Participant has tested positive for COVID-19 within the last 45 days (excluding test
results received after current onset of symptoms)
- Participant has received antiviral medications for Influenza (Amantadine, Rimantadine,
Ribavirin, Oseltamivir, Zanamivir) in the previous 45 days
- Participant has received medication or treatment for COVID-19 infection in the last 45
days (including antivirals, convalescent plasma therapy, monoclonal antibody treatment
(mAb), Remdesivir, long-acting antibody (LAAB) treatment (Evusheld)
5.
CTRI; 08-11-2023; TrialID: CTRI/2023/11/059689
Clinical Trial Register
| ICTRP | ID: ictrp-CTRI202311059689
RESUMEN
Condition:
Health Condition 1: K509- Crohns disease, unspecifiedIntervention:
Intervention1: Ustekinumab (Stelara™): 130 mg Ustekinumab will beadministered intravenously at week 0 and Subsequent
dosing of 90 mg subcutaneously from week 8 to Week 24 (every 8 weeks).
Intervention2: Ustekinumab (Stelara™) S.C.
: S.C. Dose; 90 mg
Subsequent dosing SC (8 weekly) – 1 vial (90mg)
Control Intervention1: No applicable: No applicable
Primary outcome:
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)Timepoint: over 38 weeksCriteria:
Inclusion criteria: 1)Adult subjects who are diagnosed as Crohn’s disease for at least 3 months with moderate to severe disease based on CDAI score of 220-450 at baseline2) Subject should have either failed or were intolerant to immunomodulators or corticosteroids, or were corticosteroid dependent, or have failed, or were intolerant to one or more biological treatments. Subjects who were receiving the above should have received continuous therapy for adequate duration at the highest recommended doses or should have been unable to receive the full course of full-dose therapy because of intolerance, toxicity, or contraindications
3) Women of childbearing potential or men capable of fathering children must be using highly effective birth control measures during the study and must be willing to use such birth control measures. Donation of ova, oocytes, or sperm for the purpose of assisted reproduction during the study and for a period of 16 weeks after the last administration of study interventions are prohibited. Female subjects of childbearing potential must test negative for pregnancy by HCG at screening visit.
4) Are considered eligible per the following tuberculosis (TB) screening criteria:
a. Have no history of TB prior to screening.
AND
b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
AND
c. Have had no recent close contact with a person with active TB, or if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study drug.
AND
d. Within 6 weeks prior to the first administration of study drug, have a negative QuantiFERON- TB Gold and a negative tuberculin skin test result, OR have a newly identified positive QuantiFERON-TB Gold or tuberculin skin test result during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study drug. A subject whose first QuantiFERON-TB test result is indeterminate should have the test repeated. In the event that additional QuantiFERON-TB test result is persistently indeterminate, the subject should also initiate treatment for latent TB in order to enter the study.
AND
e. Have a chest radiograph (both Postero-anterior and lateral views), taken within 3 months prior to the first administration of study drug and read by a qualified radiologist, with no evidence of current active TB or old inactive TB.
5) Have screening laboratory test results as follows:
a. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) level not exceeding 2.0 times the ULN for the laboratory conducting the test.
b. Serum creatinine not exceeding 1.7 mg/dL
6) It is recommended that subjects are up to date on age-appropriate vaccinations prior to screening as per routine local medical guidelines. For study subjects who received locally approved (and including emergency use-authorized) COVID-19 vaccines recently prior to study entry, follow applicable local vaccine labelling, guidelines, and standards of care for subjects receiving immune-targeted therapy when determining an appropriate interval between vaccination and study enrolment.
Exclusion criteria: 1. Has a history of treatment with interleukin-12 and/or interleukin-23 antagonists.
2. Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with ustekinumab
3. Has stool culture or other examination positive for an enteric pathogen (done at the discretion of the Principal Investigator), including Clostridium difficile toxin, in previous 4 months, unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen.
4. Has a history of latent or active granulomatous infection prior to screening. Anyother active or latent granulomatous infections (including active tuberculosis [TB]) will be excluded.
5. Had a serious infection (including but not limited to, hepatitis, pneumonia, abscess, sepsis, or pyelonephritis), or have been hospitalized for an infection, or have been treated with IV antibiotics for an infection within 2 months prior to first administration of study drug. Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery. Subjects with active fistulas may be included if there is no anticipation of a need for surgery and no abscesses are currently identified. Less serious infections (e.g., acute upper respiratory tract infection, simple urinary tract infection, simple gastrointestinal infection) need not be considered exclusionary at the discretion of the investigator.
6. Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (e.g., bronchiectasis), sinusitis, recurrent urinary tract infection (e.g., recurrent pyelonephritis, chronic nonremitting cystitis), an open, draining, or infected skin wound, or an ulcer.
7. Are currently infected (including carriers) with Human Immunodeficiency Virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). For subjects who are not
eligible for this study due to HIV, HCV, or HBV test results, consultation with a physician with expertise in the treatment of those infections is recommended.
8. Has any known malignancy or has a history of malignancy (with the exception of basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to screening) or a history of lymphoproliferative disease
9. Are pregnant, breastfeeding, or planning a pregnancy or fathering a child during the study or within 6 months after receiving the last administration of study drug.
10. Has a known clinically significant hypersensitivity to ustekinumab or to any of the excipients.
11. Has been treated with any investigational drug in last 6 months prior to the first administration of study drug
12. Has received, or are expected to receive, any live virus or bacterial vaccination within 3 months before the first administra
6.
ChiCTR; 2023-11-07; TrialID: ChiCTR2300077397
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2300077397
RESUMEN
Condition:
Novel Coronavirus Pneumonia (COVID-19)Intervention:
study group:Study Vaccine Administration;control group:Control Vaccine Administration;Primary outcome:
Live virus neutralizing antibody against current major SARS-CoV-2 VOC;incidence rate of adverse reaction/event;Criteria:
Inclusion criteria: (1) Adults aged 18 and above who are able to provide legal identity certificate. No gender limit.(2) Healthy subjects or those with underlying disease(such as coronary heart disease, hypertension, diabetes, obesity, etc.) but in stable control;
(3) The subjects shall fully understand the content of the informed consent form and the vaccines to be administered in this vaccination, voluntarily sign the informed consent form, and the subjects themselves or their authorized persons* have the ability to use the thermometer, scale and fill in the diary card and contact card as required;
Note: Authorized person* refers to the person who assists the volunteer in using the thermometer and scale and filling in diary card/contact card.
(4) The subjects shall be able to communicate well with the investigators, as well as understand and comply with the requirements of this study;
(5) Have received primary immunization with COVID-19 vaccines without containing antigenic components of the XBB variant at least 3 to 6 months ago of the most recent dose*;
*primary immunization:received 2 doses of inactivated COVID-19 vaccines, or 3 doses of Zhifei Recombinant Novel Coronavirus Vaccine(CHO Cell), or 1 dose of Ad5-nCoV(Cancino Biologics).
Vaccination interval:for those who have completed primary immunization only, at least 3 months ago of the most recent dose, and for those who have received 1 dose of booster immunization, at least 6 months ago of the most recent vaccination.
(6) For female subjects: having used effective methods of contraception after their last menstrual period prior to vaccination of this study ,or having no childbearing potential.
(7) No history of COVID-19 infection in the last 3 months;
(8) Negative SARS-CoV-2 antigen test result within 24 hours before enrollment.
Exclusion criteria: (1) Positive result for SARS-CoV-2 IgM antibody test on the day of vaccination;
(2) Fever within the last 72 hours or axillary temperature was=37.3?on the day of the vaccination;
(3) Antipyretic analgesic and anti allergic drugs used in the last 72 hours;
(4) Female volunteer who is known to be pregnant, breastfeeding, or was positive in urine pregnancy test on the day of vaccination, or plans to discontinue effective contraception (e.g., intrauterine or implantable contraceptive devices, oral contraceptives, injectable or buried contraceptives, extended-release localized contraceptives, intrauterine devices, condoms (for males), diaphragms, cervical caps, etc.) for 12 months after vaccination;
(5) Prior history of allergic reaction or anaphylaxis to any vaccine or drug, e.g., urticaria, serious eczema, difficulty breathing, laryngeal edema, and angioedema etc.; or allergy to essential disinfectant substances used in the study (e.g., 75% alcohol);
(6) Receipt of any vaccine within 14 days prior to the vaccination;
(7) Have participated in or planned to participate in clinical trials of other drugs within 12 months after vaccination;
(8) Hereditary hemorrhagic tendency or coagulation dysfunction (e.g., cytokine defects, coagulation disorders or platelet disorder), or a history of significant bleeding;
(9) Asplenia or functional asplenia;
(10) Have a serious illness that is not well controlled, such as a malignant tumor, cardiac arrest within the previous 30 days, or other major uncontrolled illness that the investigator believes may pose risks;
(11) Long-term use (continuous used=14 days) of immunosuppressants or other immunomodulators (e.g., glucocorticoids: prednisone or similar drugs; interferons etc.) within 6 months prior to the vaccination of the investigational vaccines in this study, except for topical medications (e.g., ointments, eye drops, inhalants or nasal sprays). However, the topical medications should not exceed the dose as recommended in the package insert.
(12) Having received immunoglobulins and/or blood products within 3 months prior to the vaccination in this study;
(13) Suspected or known alcohol dependency or drug abuse, which may affect safety evaluation or subject compliance;
(14) Planning to permanently move away from the study area before study completion or leave the local area for a long time during the period of study visits;
(15) Any other situation that is not suitable for the volunteers to participate in the study at the discretion of the investigator.
7.
CTRI; 06-11-2023; TrialID: CTRI/2023/11/059593
Clinical Trial Register
| ICTRP | ID: ictrp-CTRI202311059593
RESUMEN
Condition:
Health Condition 1: C50- Malignant neoplasm of breastIntervention:
Intervention1: Paclitaxel protein-bound particles (albuminbound), 100 mg per vial: Each eligible patient will be administered a single intravenous infusion (260 mg/m2) of the test productControl Intervention1: ABRAXANE® (Paclitaxel Protein-bound Particles for Injectable Suspension) (albumin-bound): Each eligible patient will be administered a single intravenous infusion (260 mg/m2) of the reference product
Primary outcome:
Cmax, AUCt, AUCiTimepoint: Considering the minimum washout period, expected study duration of clinical part is 9 week from the day of screeningCriteria:
Inclusion criteria: Inclusion criteria:Patient will be eligible for inclusion in this study only if all of the following criteria apply:
1. Female patient of 18 to 65 years of age (both inclusive).
2. Breast cancer with one of the following:
a. Has histological or cytological confirmed metastatic breast cancer after failure of combination chemotherapy for metastatic disease.
b. Has had a relapse within 6 months of adjuvant chemotherapy.
c. Has histological or cytological confirmed breast cancer who is a candidate for albumin bound paclitaxel therapy in accordance with the standard of care (NCCN guidelines- Breast Cancer) as per PI judgement.
Note: In the case of items a and b above, prior therapy should have included an anthracycline, such as doxorubicin, daunorubicin, mitoxantrone or other related compounds unless clinically contraindicated.
3. Adequate hematological, renal, and hepatic function as defined by the following screening laboratory values obtained at screening and prior to randomization (patients should not have received a transfusion within 7 days before the screening laboratory assessments):
a. Absolute neutrophil count (ANC) = 1,500 cells/mm3 (1.5x109/L)
b. Platelet count = 100,000 cells/mm3 (100x109/L)
c. Hemoglobin = 9 g/dL
d. Creatinine clearance > 60 mL per minute (using Cockcroft-Gault formula)
Formula of creatinine clearance: Crcl equals to (140 - age) × body weight (Kilogram weight)/plasma creatinine (mg/dl) × 72 x 0.85 (considering female patients).
Total bilirubin = 1.5 x ULN (Upper Limit of Normal)
e. AST (SGOT) = 2.5 x ULN
f. ALT (SGPT) = 2.5 x ULN
g. Serum albumin = 3.0 gm/dL
h. Alkaline phosphatase < 2.5 x ULN
4. Eastern Cooperative Oncology Group (ECOG) performance status = 2
5. All other clinical laboratory parameters and ECG findings deemed normal or not clinically significant judged by the Investigator.
6. Body surface area (BSA) that is within 1.2 to 2.2 m2, calculated using the Du Bois Formula.
7. Patient with life expectancy of at least 3 months at the time of enrollment.
8. Female patient with postmenopausal status or female patient of childbearing
potential with negative pregnancy test [negative serum pregnancy test (ß-hCG) at screening, and negative urine pregnancy test prior to each dose of study drug] must agree to practice an acceptable method of contraception throughout the study period and for at least 6 months after last dose of study drug. No history of pregnancy in last 30 days prior to randomization.
Women who are not postmenopausal = 52 weeks or surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, bilateral tuballigation) prior to screening are considered of child-bearing potential.
9. Patient who had taken COVID-19 vaccine, must have recovered from vaccine related adverse events before being screened for the study.
10. Patient willing to provide written informed consent and able to adhere to all protocol requirements and study procedures throughout the study.
11. Ability to comprehend and be informed of the nature of the study, as assessed by study clinic staff.
Exclusion criteria: Exclusion Criteria:
Patient will not be eligible for inclusion in this study if any of the
following criteria apply:
1. History of allergy or hypersensitivity reactions to a paclitaxel or the components of paclitaxel protein-bound particles for injectable suspension (albumin-bound) including, albumin and PEG or any related compound at any dose.
2. Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal (e.g., intra-abdominal inflammation), cardiovascular (e.g., congestive heart failure, ventricular arrhythmia, myocardial infarction, unstable angina pectoris), cerebrovascular, pulmonary (e.g., interstitial lung disease), endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological (e.g., bleeding diathesis or coagulopathy) disease or condition other than breast cancer unless determined as not clinically significant by the Investigator.
3. Patient with presence of uncontrolled hypertension or diabetes mellitus.
4. History of any other malignancy within the last 5 years.
5. Ongoing or planned lactation during study period.
6. Acute active infection requiring treatment from screening till randomization.
7. Receipt of other taxane product within the 30 days prior to randomization.
8. The patient receives treatment with any:
a. Hormonal therapy 2 weeks prior to first dose
b. Chemotherapy (except for palliative bisphosphonate therapy for bone pain which can be administered as clinically indicated) 4 weeks prior to first dose
c. Investigational drug or immunotherapy within 4 weeks prior to first dose
d. Concurrent radiation therapy (except for palliative radiotherapy for bone pain which can be administered as clinically indicated)
9. Incomplete recovery from any toxicities from previous chemotherapy, hormone therapy, immunotherapy, or radiotherapies Grade 1 or higher by current version of CTCAE, with the exception of alopecia.
10. Patient with preexisting peripheral neuropathy of NCI toxicity scale >2.
11. Major surgery within 30 days prior to randomization, or incomplete recovery from prior major surgery.
12. Known history or presence of any clinically significant disease or condition other than cancer unless determined as not clinically significant by the Investigator.
13. Known history or presence of:
a. Infection with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
b. Alcohol or drug abuse or dependence within one year prior to randomization
14. Patient with known CNS metastasis.
15. Participation in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or the use of investigational devices with therapeutic intent within 30 days or period equivalent of 5 half-lives of the investigational intervention prior to randomization.
16. Receipt of any known CYP2C8 and CYP3A4 inhibitor (e.g.ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) or inducer (e.g., rifampicin, carbamazepine, phenytoin, efavirenz, and nevirapine) 14 days before randomization.
17. Patient having signs and symptoms suggestive of COVID-19 (such as fever, dry cough, difficulty in breathing and fatigue).
18. Consumption of any grapefruit, star fruit
8.
IRCT; 2023-11-06; TrialID: IRCT20231008059655N1
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20231008059655N1
RESUMEN
Condition:
Covid-19.COVID-19, virus identified;U07.1
Intervention:
Intervention 1: Intervention group:Patients with covid 19 are treated with the appropriate dose of remdesivir (Ronak Pharmaceutical Company) (The first day with a dose of 200 mg and the second, third, fourth and fifth day with doses of 100 mg) and the appropriate dose of nebulized low molecular weight heparin (Ronak Pharmaceutical Company) (0.5 mg per kg) at the same time as receiving Remdesivir for five days. Then every day after taking the drugs, the patient s peak expiratory flow rate is recorded by the peak flowmeter and the patient s vital signs are also recorded.? The person who administers the medicine in the two groups will be different from the person who examines the results of the interventions. The interventions are performed by the emergency nurse, but the peak flowmetry results are measured by an intern who is unaware of the intervention groups. Also, the patients and the person who analyzes the results of the study will not know about the treatment groups. Intervention 2: Control group: Patients with covid 19 are treated with the appropriate dose of Remdesivir (Ronak Pharmaceutical Company) (The first day with a dose of 200 mg and the second, third, fourth and fifth day with doses of 100 mg) and the appropriate dose of nebulized distilled water (0.5 mg per kg) at the same time as receiving Remdesivir for five days. Then every day after taking the drugs, the patient s peak expiratory flow rate is recorded by the peak flowmeter and the patient s vital signs are also recorded.?The person who administers the medicine in the two groups will be different from the person who examines the results of the interventions. The interventions are performed by the emergency nurse, but the peak flowmetry results are measured by an intern who is unaware of the interventionPrimary outcome:
Peak expiratory flow rate. Timepoint: In this study, the time periods of measuring the peak expiratory flow rate will be measured on days 1, 2, 3, 4 and 5 after receiving the drug. Method of measurement: Peak flow meter.;Saturation O2. Timepoint: In this study, the time periods of measuring oxygen saturation are measured on days 1, 2, 3, 4 and 5 after receiving the drug. Method of measurement: Pulse oximeter.Criteria:
Inclusion criteria: Positive Covid-19 testPatients who are treated on an outpatient basis
Exclusion criteria: Patients with poor general condition and hospitalization in the emergency room
Patients with acute medical problems
9.
CTRI; 06-11-2023; TrialID: CTRI/2023/11/059574
Clinical Trial Register
| ICTRP | ID: ictrp-CTRI202311059574
RESUMEN
Condition:
Health Condition 1: I70- AtherosclerosisIntervention:
Intervention1: NIL: NILPrimary outcome:
The proportion of Coronary Artery DiseaseRisk factors for Coronary artery disease
Determinants of Coronary artery diseaseTimepoint: At the recruitment
Criteria:
Inclusion criteria: Patients of age 18 years and above (have been vaccinated or not)Participants who are undergoing coronary angiogram at the Department of Cardiology Kasturba Hospital Manipal
Able to read write and converse in English/Kannada
Exclusion criteria: Participants who are not willing to give consent
Patients with congenital heart disease
Patients with known genetic diseases and related cardiomyopathies
Patients with rheumatic heart diseases
Patients with major psychiatric disorders, dementia or delirium.
10.
IRCT; 2023-11-04; TrialID: IRCT20230522058257N1
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20230522058257N1
RESUMEN
Condition:
Overweight and obesity.Overweight and obesity
Intervention:
Intervention 1: Intervention group 1: consume 120 cc of yogurt containing 10^9 CFU Ackermansia muciniphila befor meal daily for 8 weeks. Intervention 2: Intervention group 2: consume 120 cc of yogurt containing 10^9 CFU Lactobacillus Acidophilus befor meal daily for 8 weeks. Intervention 3: Control group: consume 120 cc of low fat yogurt befor meal daily for 8 weeks.Primary outcome:
Waist circumference. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: stadiometer.;Body weight. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: scale.;Body mass index. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: By calculating using the formula with using height and weight.Criteria:
Inclusion criteria: Aged 20 - 50 years and not being menopause for femalesBeing overweight or obese (Body mass index higher than 25)
Not allergic to milk protein and Not lactose intolerant,not being gluten-intolerant
Not suffering from known endocrine-related obesity, Inflammatory bowel disease, Irritable bowel syndrome, nouropathy, gastroparesis and gastrointestinal disorders at the beginning of the study
Not suffering from thyroid diseases, diabetes, kidney disease, rheumatic diseases and migraine headache at the baseline
did not use antibiotics for 2 months before the beginning of the study
didn't take probiotic, prebiotic, and omega 3 supplements for 1month before the study
Not taking part in other studies for 6 months before the study
No weight reduction over 6 Kg in the last 3 months prior to the study
no history of hospitalization or any surgery and bariateric surgery for 3 months before the study and 6 months after entering the study
Not following special diets such as vegetarian or gluten free or weight-reducing diets
Not infected with Covid-19 or any other infections or any hospitalization for 1 month before the study
Exclusion criteria: planning for pregnancy for 6 months after the study and not having breast-feeding
heavy alcohol use
11.
ClinicalTrials.gov; 03/11/2023; TrialID: NCT06119854
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06119854
RESUMEN
Condition:
Misinformation;Vaccine Hesitancy;Anxiety;Depression;COVID-19Intervention:
Behavioral: Attitudinal inoculation;Behavioral: Cognitive-behavioral therapy-informed intervention;Behavioral: Conventional public health messagingPrimary outcome:
Self-reported receipt of COVID vaccine dose by 4 weeks post-interventionCriteria:
Inclusion Criteria: Potentially eligible CHASING COVID Cohort participants will be
introduced to the study by email and/or SMS text. Interested individuals will then complete
a short online screener. To be eligible, individuals must: 1) Be actively engaged in the
CHASING COVID Cohort study (completed >1 survey or specimen collection since January 1,
2022); 2) have a last COVID-19 vaccine dose prior to September 11, 2023 (when updated
monovalent vaccine was introduced); 3) currently reside in the US or a US territory; and 4)
read and understand English.
Exclusion Criteria: 1) Have never received a dose of a COVID-19 vaccine.
12.
ClinicalTrials.gov; 03/11/2023; TrialID: NCT06122714
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06122714
RESUMEN
Condition:
Healthy ParticipantsIntervention:
Drug: AZD4144 Part A;Drug: AZD4144 Part B;Drug: Placebo Part A;Drug: Placebo Part BPrimary outcome:
Number of participants with adverse events (AEs)Criteria:
Inclusion criteria:
- Females must have a negative pregnancy test, must not be lactating and must be of
non-childbearing potential.
- Have a BMI between 18 and 32 kg/m2 inclusive at both Screening and Admission and weigh
at least 45 kg at Screening.
- For healthy Japanese cohorts (Part A2 and Part B2): healthy male and female (of
non-childbearing potential) participants are to be Japanese, defined as having both
parents and four grandparents who are Japanese. This included second and third
generation participants of Japanese descent whose parents or grandparents are living
in a country other than Japan.
- For healthy Chinese cohort (Part A3): healthy male and female (of non-childbearing
potential) Chinese participants for whom both parents and all grandparents are Chinese
and not lived outside of China for more than 10 years.
Exclusion criteria:
- History of any clinically important disease or disorder which, in the opinion of the
Investigator, may either put the participant at risk because of participation in the
study.
- History or presence of gastrointestinal, hepatic or renal disease or any other
condition known to interfere with absorption, distribution, metabolism or excretion of
drugs.
- Any clinically important illness, medical/surgical procedure or trauma.
- Clinically significant serious active and chronic infections.
- Bacillus Calmette-Guérin vaccine within one year prior to signing the ICF.
- Any abnormal laboratory values at the Screening Visit.
- Any positive result on Screening for serum Hepatitis B surface antigen (HBsAg),
anti-Hepatitis B core (HBc), hepatitis C antibody, or Human Immunodeficiency Virus
(HIV).
- Any cardiac abnormalities.
- History of alcohol abuse or drug abuse.
- Current smokers or those who have smoked or used nicotine products.
- History of severe allergy/hypersensitivity or ongoing clinically important
allergy/hypersensitivity.
- Clinical signs and symptoms consistent with COVID-19.
- In addition, any of the following is regarded as a criterion for exclusion from the
genetic research:
1. Previous bone marrow transplant
2. Non-leukocyte depleted whole blood transfusion within 120 days of the date of the
genetic sample collection
13.
ClinicalTrials.gov; 03/11/2023; TrialID: NCT06124131
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06124131
RESUMEN
Condition:
Health Behavior;Colorectal Cancer;Influenza;COVID-19;Vaccine Hesitancy;Vaccine-Preventable Diseases;Healthcare Patient AcceptanceIntervention:
Behavioral: Financial incentive for colorectal cancer screening;Behavioral: Financial incentive for flu shot;Behavioral: Financial incentive for COVID-19 shotPrimary outcome:
Difference in proportion of participants completing colorectal cancer screening between study armsCriteria:
Inclusion Criteria:
- Age 45 to 75
- Receive care at participating primary care clinic
- Due for colorectal cancer screening
- Ability to understand and speak English
Exclusion Criteria:
- Currently participating in another clinical trial or research study on colorectal
cancer screening
- Unable or unwilling to give informed consent
14.
ChiCTR; 2023-11-02; TrialID: ChiCTR2300077260
Clinical Trial Register
| ICTRP | ID: ictrp-ChiCTR2300077260
RESUMEN
Condition:
COVID-19Intervention:
The treatment group:standard care plus Quinolone antibiotics at a dose of500 mg once daily for 7 days;control group:standard care ;
Primary outcome:
the incidence of bacterial superinfections within 28 days after COVID-19;Criteria:
Inclusion criteria: 1.SARS-Cov-2 infection (RT-PCR test or antigen dectection for SARS-CoV-2 was performed and it is positive)2.At the time of visit or admission, no acute active bacterial infection was present (last blood routine: WBC < 10 ×10^9/L, N < 70%).
3. Fewer than 7 days since symptom onset or aggravation of pre-existing symptoms
Exclusion criteria: 1.No Informed Consent;
2.Use of any type of antibiotic in the week prior to recruitment;
3.History of severe ventricular cardiac arrhythmia or electrocardiogram with corrected QT interval
(QTc) =480 ms;
4.With severe liver disease (total bilirubin (TBIL) =2 times the upper limit of normal, alanine aminotransferase (ALT), aspartate aminotransferase (AST) =3 times the upper limit of normal);
5.Chronic renal failure (estimated glomerular filtration rate <30 mL/min/1.73 m2);
6.History of epilepsy;
7.History of myasthenia gravis;
8.Known allergy to quinolone;
9.Age: <18 years old;
10.Pregnant and lactating women or those who planned to have children during the trial period and within 6 months after the end of the trial;
11.People who are participating in other clinical trials or are using an investigational drug.
15.
ClinicalTrials.gov; 02/11/2023; TrialID: NCT06121856
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06121856
RESUMEN
Condition:
Diabetes MellitusIntervention:
Device: VerioVue Enhancements BGMSPrimary outcome:
Performance evaluation: blood glucose monitoring system accuracy: BGMS vs reference instrument using arterial bloodCriteria:
Inclusion Criteria:
Age - The potential Subject is at least 16 years old. Language - Subject reads and
understands English. Informed Consent - The potential subject must read the Participant
Information Sheet and sign the Informed Consent Form.
Subject agrees to provide relevant demographic, medical history, and prescription
medication information.
The subject agrees to allow study staff access to medical records where necessary.
The Subject agrees to all aspects of the study process, including arterial blood draws
performed by an HCP.
Exclusion Criteria:
Age - Subject is under 16 years old. Current Covid-19 positive test result.
16.
ClinicalTrials.gov; 02/11/2023; TrialID: NCT06122831
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06122831
RESUMEN
Condition:
MyelofibrosisIntervention:
Drug: TQ05105 Tablets;Drug: TQB3617 CapsulesPrimary outcome:
Maximal tolerance dose (MTD);Recommended phase II dose (RP2D);=35% reduction in spleen volume (SVR35)Criteria:
Inclusion Criteria:
- Voluntary and signed informed consent, good compliance.
- Age: 18 or above (when signing the informed consent form); Eastern Cooperative
Oncology Group (ECOG) performance status (PS) score of 0 or 2; Life expectancy = 24
weeks.
- Patients diagnosed with Primary myelofibrosis (PMF), post polycythemia vera
myelofibrosis (post PV MF), or post essential thrombocythemia myelofibrosis (post ET
MF)
- According to the dynamic international prognostic scoring system (DIPSS), patients
with intermediate or high risk of bone marrow fibrosis were evaluated.
- Patients with poor efficacy of JAK inhibitors (for phase Ib and phase II cohort 2)
- Patients who had not received JAK inhibitor treatment (for phase II cohort 1).
- Spleen enlargement.
- Peripheral blood primary cells and bone marrow primary cells were =10%.
- No growth factor, colony stimulating factor, thrombopoietin or platelet transfusion
was received within 2 weeks before the examination, and the blood routine indexes met
the requirements within 7 days before the first administration.
- The Main organ function is normal.
- Men and women of childbearing age should agree to use contraceptive measures (such as
intrauterine devices, contraceptives, or condoms) during the study period and within 6
months after the end of the study. Serum human chorionic gonadotrophin (HCG) test is
not negative within 7 days before the first administration and must be non-lactating
patients.
Exclusion Criteria:
- Patients who have previously received allogeneic stem cell transplantation, or
received autologous stem cell transplantation within 3 months before the first
administration, or recently planned stem cell transplantation;
- Previous treatment with BET inhibitors;
- Patients who have previously undergone splenectomy, or received splenic radiotherapy
within 6 months before the first administration;
- Use of any MF medications, any immunomodulators, androgens, any immunosuppressive
agents, erythropoietin, aspirin > 100 mg/day within 2 weeks prior to first
administration;
- Other malignancies within 3 years prior to first administration or currently present.
- Patients with multiple factors (such as inability to swallow, postoperative
gastrointestinal resection, acute and chronic diarrhea, intestinal obstruction, etc.)
affecting oral or absorption of drugs;
- Major surgical treatment or significant traumatic injury within 4 weeks prior to first
administration;
- Presence of congenital bleeding disorder and congenital coagulopathy;
- Patients who had arterial/venous thrombosis events within 6 months before the first
administration.
- Have a history of mental drug abuse, or have a mental disorder.
- Active or uncontrolled severe infection;
- Active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection and HCV
RNA positive, or active Corona Virus Disease 2019 (COVID-19) infection;
- Patients with grade III or above congestive heart failure, unstable angina pectoris or
myocardial infarction, or arrhythmia requiring treatment, or QT interval prolongation
within 6 months before the first administration;
- Unsatisfactory blood pressure control despite standard therapy;
- Patients with renal failure requiring hemodialysis or peritoneal dialysis;
- Patients newly diagnosed with pulmonary interstitial fibrosis or drug-related
interstitial lung disease within 3 months before the first administration;
- Patients with a history of immunodeficiency disease or organ transplantation;
- Patients with epilepsy requiring treatment;
- Patients who have received Chinese patent medicines with anti-tumor indications
specified in the approved drug package insert of China National Medical Products
Administration (NMPA) within 2 weeks before the first administration;
- Patients with uncontrolled pleural effusion, pericardial effusion or ascites;
- There was a history of attenuated live vaccine inoculation within 4 weeks before the
first administration, or attenuated live vaccine inoculation was planned during the
study period.
- People with known hypersensitivity to the study drug and excipients;
- Patients diagnosed as active autoimmune diseases within 2 years before the first
administration;
- Those who participated in and used other anti-tumor clinical trial drugs within 4
weeks before the first administration (except JAK inhibitor-related clinical trials).
- According to the judgment of the investigators, some situations seriously endanger the
safety of the subjects or affect the subjects to complete the study.
17.
ClinicalTrials.gov; 02/11/2023; TrialID: NCT06124495
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06124495
RESUMEN
Condition:
Bioequivalence;Diabetes Mellitus, Type 2Intervention:
Drug: Sitagliptin/Metformin HCl 50/500 mg extended release film-coated tabletPrimary outcome:
Peak Plasma Concentration (Cmax);Area under the plasma concentration versus time curve (AUC) 0-t;Area under the plasma concentration versus time curve (AUC) 0-inf (Metformin only)Criteria:
Inclusion Criteria:
1. Healthy adult male and female subjects aged = 18 and = 55 years.
2. Subjects is a non-or ex-smoker (An ex-smoker is defined as someone who completely
stopped smoking for at least 6 months before screening).
3. With a weight = 50.00 kg.
4. With a body mass index (BMI) = 18.5 kg/m2 and = 27.0 kg/m2. This BMI range covers both
COFEPRIS (18.0 to 27.0 kg/m2) and GCC (18.5 to 30.0 kg/m2) requirements.
5. Found healthy according to the clinical laboratory results and physical examination
(performed within 28 days prior to the dosing on period 1).
6. Have a normal 12-lead ECG and vital signs.
7. Have laboratory test results within the laboratory's stated normal range; if not
within this range, they must lack of clinical significance as judged by the PI or
responsible physician.
8. If the subject of the study is female and childbearing potential / fertile (a woman is
considered fertile from first menstruation and until she becomes postmenopausal, or
permanently sterile), and agrees to use ANY ONE of the following forms of effective
contraception / birth control (but not limited to) from the time of enrollment into
the study and until at least 7 days after the last study drug administration, as
judged by the PI considering the pharmacology of IP(s):
1. Established use of oral, transdermal, injected or subdermal implanted hormonal
methods.
2. Intrauterine device (IUD or intrauterine system (IUS).
3. Barrier methods: e.g., diaphragm, cervical cap or condom (male or female condom).
4. Spermicidal: e.g., spermicidal foam, sponges or film.
5. Undergone bilateral tubectomy.
6. Accept to remain abstinent: When this is in line with the preferred and usual
lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation,
symptothermal, post-ovulation methods) and withdrawal are not acceptable methods
of contraception] OR Women who are postmenopausal (defined as female with no
menses at least for the last 12 months without any medical cause) or permanently
sterilized (e.g., undergone hysterectomy, bilateral salpingectomy or oophorectomy
at least for the last 3 months).
9. If the subject of the study is male, he must be willing to use ANY ONE of the
following forms of effective contraception / birth control (but not limited to) and
willing not to donate sperm; from the time of enrollment into the study and until at
least 7 days after the last study drug administration, as judged by the PI;
1. Willing to remain abstinent: When this is in line with the preferred and usual
lifestyle of the subject.
2. Willing to use a male condom.
3. Male sterilization (men who have had vasectomy, at least 3 months previous to
drug administration).
10. Subject able to communicate effectively and voluntarily agreed to participate in this
study by signing written informed consent after being informed sufficiently about
study aspects like objectives, study procedures, characteristics of the
investigational drug, expected adverse events.
11. Subject willing to adhere to protocol requirements as evidenced by signing the
informed consent form approved by the REC & RC.
Exclusion Criteria:
1. Have any history of allergy or hypersensitivity to sitagliptin and metformin or to any
of its metabolites/derivatives or related drugs or excipients.
2. Have a positive test result for HBs Ag or HCV Ab or HIV antibodies (types 1 and 2) or
VDRL.
3. The study drug is contraindicated for medical reasons for the subject as per protocol
section 3.7.
4. Have any history or presence of clinically significant cardiovascular, pulmonary,
hepatic, renal, gastrointestinal, hematological, neurological or psychiatric disease
or disorder (e.g., subjects with uncontrolled hypertension, phaeochromocytoma,
carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder and acute
confusional states) as judged by the PI considering the pharmacology of IP(s).
5. Presence of gastrointestinal, hepatic or kidney disease, or surgery or any other
condition known to interfere with the absorption, distribution, metabolism or
excretion of drugs or known to potentiate or predispose to undesired effects.
Or Subjects with a history of gastrointestinal disorder or surgery which may affect
the absorption of investigational drug.
6. Have history or presence of Corona Virus Disease (COVID-19) during the last 30 days
prior to dosing of period 1.
Or Have history of vaccination (any dose) for COVID-19 during the last 14 days prior
to dosing of period 1.
Or Any planned vaccination for COVID-19 during the study period.
7. Have history or presence of cancer.
8. Have a history or evidence of drug abuse or alcohol abuse.
9. Have a history of smoking cigarettes during the last 6 months prior to screening.
10. Have any history of gastrointestinal ulcers / bleeding.
11. Have difficulty in swallowing solid medications such as tablet.
12. Have a history or evidence of difficulty with donating blood.
13. Have clinically significant abnormal laboratory tests results.
14. Have a systolic blood pressure < 90 or > 140 mmHg or diastolic blood pressure is < 60
or > 90 mmHg
15. Have a pulse rate less than 60 bpm or greater than 100 bpm (lower range will be
accepted up to 45 bpm in case of athlete).
16. Have used any prescribed medication during the last 14 days preceding the first
dosing, or use OTC, herbal products during the last 7 days or use medicinal enzyme
inhibitors / inducers during 30 days preceding the first dosing.
17. Have participated in a drug research study the last 3 months or donated blood within
the last 3 months.
18. Have a positive result for the alcohol test (breath / saliva) or drugs of abuse test
[Cannabinoids (Marijuana/Tetrahydrocannabinol-THC), Cocaine, Opiates/Morphine,
Amphetamine, Methamphetamine and Benzodiazepines] performed during screening.
19. Female subject, who is currently breast feeding or a who is pregnant or who is likely
to become pregnant during the study.
20. Female subject has a positive pregnancy test result.
21. Unwillingness or inability to comply with the instructions on the restrictions and/or
study procedures described in this Protocol.
22. If the PI considers, for any reason, that the volunteer is not a suitable candidate to
18.
ClinicalTrials.gov; 02/11/2023; TrialID: NCT06124547
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06124547
RESUMEN
Condition:
Bioequivalence;Diabetes Mellitus, Type 2Intervention:
Drug: Sitagliptin/Metformin HCl 50/500 mg extended release film-coated tabletPrimary outcome:
Peak Plasma Concentration (Cmax);Area under the plasma concentration versus time curve (AUC) 0-t;Area under the plasma concentration versus time curve (AUC) 0-inf (Metformin only)Criteria:
Inclusion Criteria:
1. Healthy adult male and female subjects aged = 18 and = 55 years.
2. Subjects is a non-or ex-smoker (An ex-smoker is defined as someone who completely
stopped smoking for at least 6 months before screening).
3. With a weight = 50.00 kg.
4. With a body mass index (BMI) = 18.5 kg/m2 and = 27.0 kg/m2. This BMI range covers both
COFEPRIS (18.0 to 27.0 kg/m2) and GCC (18.5 to 30.0 kg/m2) requirements.
5. Found healthy according to the clinical laboratory results and physical examination
(performed within 28 days prior to the dosing on period 1).
6. Have a normal 12-lead ECG and vital signs.
7. Have laboratory test results within the laboratory's stated normal range; if not
within this range, they must lack of clinical significance as judged by the PI or
responsible physician.
8. If the subject of the study is female and childbearing potential / fertile (a woman is
considered fertile from first menstruation and until she becomes postmenopausal, or
permanently sterile), and agrees to use ANY ONE of the following forms of effective
contraception / birth control (but not limited to) from the time of enrollment into
the study and until at least 7 days after the last study drug administration, as
judged by the PI considering the pharmacology of IP(s):
1. Established use of oral, transdermal, injected or subdermal implanted hormonal
methods.
2. Intrauterine device (IUD or intrauterine system (IUS).
3. Barrier methods: e.g., diaphragm, cervical cap or condom (male or female condom).
4. Spermicidal: e.g., spermicidal foam, sponges or film.
5. Undergone bilateral tubectomy.
6. Accept to remain abstinent: When this is in line with the preferred and usual
lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation,
symptothermal, post-ovulation methods) and withdrawal are not acceptable methods
of contraception] OR Women who are postmenopausal (defined as female with no
menses at least for the last 12 months without any medical cause) or permanently
sterilized (e.g., undergone hysterectomy, bilateral salpingectomy or oophorectomy
at least for the last 3 months).
9. If the subject of the study is male, he must be willing to use ANY ONE of the
following forms of effective contraception / birth control (but not limited to) and
willing not to donate sperm; from the time of enrollment into the study and until at
least 7 days after the last study drug administration, as judged by the PI;
1. Willing to remain abstinent: When this is in line with the preferred and usual
lifestyle of the subject.
2. Willing to use a male condom.
3. Male sterilization (men who have had vasectomy, at least 3 months previous to
drug administration).
10. Subject able to communicate effectively and voluntarily agreed to participate in this
study by signing written informed consent after being informed sufficiently about
study aspects like objectives, study procedures, characteristics of the
investigational drug, expected adverse events.
11. Subject willing to adhere to protocol requirements as evidenced by signing the
informed consent form approved by the REC & RC.
Exclusion Criteria:
1. Have any history of allergy or hypersensitivity to sitagliptin and metformin or to any
of its metabolites/derivatives or related drugs or excipients.
2. Have a positive test result for HBs Ag or HCV Ab or HIV antibodies (types 1 and 2) or
VDRL.
3. The study drug is contraindicated for medical reasons for the subject.
4. Have any history or presence of clinically significant cardiovascular, pulmonary,
hepatic, renal, gastrointestinal, hematological, neurological or psychiatric disease
or disorder (e.g., subjects with uncontrolled hypertension, phaeochromocytoma,
carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder and acute
confusional states) as judged by the PI considering the pharmacology of IP(s).
5. Presence of gastrointestinal, hepatic or kidney disease, or surgery or any other
condition known to interfere with the absorption, distribution, metabolism or
excretion of drugs or known to potentiate or predispose to undesired effects.
Or Subjects with a history of gastrointestinal disorder or surgery which may affect
the absorption of investigational drug.
6. Have history or presence of Corona Virus Disease (COVID-19) during the last 30 days
prior to dosing of period 1.
Or Have history of vaccination (any dose) for COVID-19 during the last 14 days prior
to dosing of period 1.
Or Any planned vaccination for COVID-19 during the study period.
7. Have history or presence of cancer.
8. Have a history or evidence of drug abuse or alcohol abuse.
9. Have a history of smoking cigarettes during the last 6 months prior to screening.
10. Have any history of gastrointestinal ulcers / bleeding.
11. Have difficulty in swallowing solid medications such as tablet.
12. Have a history or evidence of difficulty with donating blood.
13. Have clinically significant abnormal laboratory tests results.
14. Have a systolic blood pressure < 90 or > 140 mmHg or diastolic blood pressure is < 60
or > 90 mmHg
15. Have a pulse rate less than 60 bpm or greater than 100 bpm (lower range will be
accepted up to 45 bpm in case of athlete).
16. Have used any prescribed medication during the last 14 days preceding the first
dosing, or use OTC, herbal products during the last 7 days or use medicinal enzyme
inhibitors / inducers during 30 days preceding the first dosing.
17. Have participated in a drug research study the last 3 months or donated blood within
the last 3 months.
18. Have a positive result for the alcohol test (breath / saliva) or drugs of abuse test
[Cannabinoids (Marijuana/Tetrahydrocannabinol-THC), Cocaine, Opiates/Morphine,
Amphetamine, Methamphetamine and Benzodiazepines] performed during screening.
19. Female subject, who is currently breast feeding or a who is pregnant or who is likely
to become pregnant during the study.
20. Female subject has a positive pregnancy test result.
21. Unwillingness or inability to comply with the instructions on the restrictions and/or
study procedures described in this Protocol.
22. If the PI considers, for any reason, that the volunteer is not a suitable candidate to
receive the study drug.
19.
ClinicalTrials.gov; 02/11/2023; TrialID: NCT06124573
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06124573
RESUMEN
Condition:
Bioequivalence;Diabetes Mellitus, Type 2Intervention:
Drug: Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tabletPrimary outcome:
Peak Plasma Concentration (Cmax);Area under the plasma concentration versus time curve (AUC)0-t;Area under the plasma concentration versus time curve (AUC) 0-inf (Metformin only)Criteria:
Inclusion Criteria:
1. Healthy adult male and female subjects aged = 18 and = 55 years.
2. Subjects is a non-or ex-smoker (An ex-smoker is defined as someone who completely
stopped smoking for at least 6 months before screening).
3. With a weight = 50.00 kg.
4. With a body mass index (BMI) = 18.5 kg/m2 and = 27.0 kg/m2.
5. Found healthy according to the clinical laboratory results and physical examination
(performed within 28 days prior to the dosing on period 1).
6. Have a normal 12-lead ECG and vital signs.
7. Have laboratory test results within the laboratory's stated normal range; if not
within this range, they must lack of clinical significance as judged by the PI or
responsible physician.
8. If the subject of the study is female and childbearing potential / fertile (a woman is
considered fertile from first menstruation and until she becomes postmenopausal, or
permanently sterile), and agrees to use ANYONE of the following forms of effective
contraception / birth control (but not limited to) from the time of enrollment into
the study and until at least 7 days after the last study drug administration, as
judged by the PI considering the pharmacology of IP(s):
g. Established use of oral, transdermal, injected or subdermal implanted hormonal
methods.
h. Intrauterine device (IUD or intrauterine system (IUS). i. Barrier methods: e.g.,
diaphragm, cervical cap or condom (male or female condom).
j. Spermicidal: e.g., spermicidal foam, sponges or film. k. Undergone bilateral
tubectomy. l. Accept to remain abstinent: When this is in line with the preferred and
usual lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation,
symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of
contraception] OR Women who are postmenopausal (defined as female with no menses at
least for the last 12 months without any medical cause) or permanently sterilized
(e.g., undergone hysterectomy, bilateral salpingectomy or oophorectomy at least for
the last 3 months).
9. If the subject of the study is male, he must be willing to use ANYONE of the following
forms of effective contraception / birth control (but not limited to) and willing not
to donate sperm; from the time of enrollment into the study and until at least 7 days
after the last study drug administration, as judged by the PI; d. Willing to remain
abstinent: When this is in line with the preferred and usual lifestyle of the subject.
e. Willing to use a male condom. f. Male sterilization (men who have had vasectomy, at
least 3 months previous to drug administration).
10. Subject able to communicate effectively and voluntarily agreed to participate in this
study by signing written informed consent after being informed sufficiently about
study aspects like objectives, study procedures, characteristics of the
investigational drug, expected adverse events.
11. Subject willing to adhere to protocol requirements as evidenced by signing the
informed consent form approved by the REC & RC.
Exclusion Criteria:
1. Have any history of allergy or hypersensitivity to sitagliptin and metformin or to any
of its metabolites/derivatives or related drugs or excipients.
2. Have a positive test result for HBs Ag or HCV Ab or HIV antibodies (types 1 and 2) or
VDRL.
3. The study drug is contraindicated for medical reasons for the subject as per protocol
section 3.7.
4. Have any history or presence of clinically significant cardiovascular, pulmonary,
hepatic, renal, gastrointestinal, hematological, neurological or psychiatric disease
or disorder (e.g., subjects with uncontrolled hypertension, phaeochromocytoma,
carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder and acute
confusional states) as judged by the PI considering the pharmacology of IP(s).
5. Presence of gastrointestinal, hepatic or kidney disease, or surgery or any other
condition known to interfere with the absorption, distribution, metabolism or
excretion of drugs or known to potentiate or predispose to undesired effects.
Or Subjects with a history of gastrointestinal disorder or surgery which may affect
the absorption of investigational drug.
6. Have history or presence of Corona Virus Disease (COVID-19) during the last 30 days
prior to dosing of period 1.
Or Have history of vaccination (any dose) for COVID-19 during the last 14 days prior
to dosing of period 1.
Or Any planned vaccination for COVID-19 during the study period.
7. Have history or presence of cancer.
8. Have a history or evidence of drug abuse or alcohol abuse.
9. Have a history of smoking cigarettes during the last 6 months prior to screening.
10. Have any history of gastrointestinal ulcers / bleeding.
11. Have difficulty in swallowing solid medications such as tablet.
12. Have a history or evidence of difficulty with donating blood.
13. Have clinically significant abnormal laboratory tests results.
14. Have a systolic blood pressure < 90 or > 140 mmHg or diastolic blood pressure is < 60
or > 90 mmHg
15. Have a pulse rate less than 60 bpm or greater than 100 bpm (lower range will be
accepted up to 45 bpm in case of athlete).
16. Have used any prescribed medication during the last 14 days preceding the first
dosing, or use OTC, herbal products during the last 7 days or use medicinal enzyme
inhibitors / inducers during 30 days preceding the first dosing.
17. Have participated in a drug research study the last 3 months or donated blood within
the last 3 months.
18. Have a positive result for the alcohol test (breath / saliva) or drugs of abuse test
[Cannabinoids (Marijuana/Tetrahydrocannabinol-THC), Cocaine, Opiates/Morphine,
Amphetamine, Methamphetamine and Benzodiazepines] performed during screening.
19. Female subject, who is currently breast feeding or a who is pregnant or who is likely
to become pregnant during the study.
20. Female subject has a positive pregnancy test result.
21. Unwillingness or inability to comply with the instructions on the restrictions and/or
study procedures described in this Protocol.
22. If the PI considers, for any reason, that the volunteer is not a suitable candidate to
receive the study drug.
20.
CTRI; 02-11-2023; TrialID: CTRI/2023/11/059478
Clinical Trial Register
| ICTRP | ID: ictrp-CTRI202311059478
RESUMEN
Intervention:
Control Intervention1: NIL: Since the study is a cross sectional study, there are no comparatorsPrimary outcome:
1.To know about the prevalence of ON in college going students of Udupi city.2. To determine the common causes, health benefits & ill effects of this behavior.Timepoint: The study will recruit all the participants, meeting the inclusion criteria from the date of CTRI approval to March 2024 since its a cross sectional study.
Criteria:
Inclusion criteria: Subjects aged 18-25 years are includedExclusion criteria: Subjects below 18 and above 25 years are excluded.
Subjects out of the selected location are excluded.