1.
IRCT; 2023-10-17; TrialID: IRCT20171007036614N4
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20171007036614N4
ABSTRACT
Condition:
Unspecified injury of lung.Unspecified injury of lung;S27.30
Intervention:
Intervention 1: Intervention group, strata 1: Herbal product formulation (containing chamomile, thyme, licorice, jujube, fig, nettle, mistletoe and hyssop) based on the basic study of Karimi et al. (Efficacy of Persian medicine herbal formulations (capsules and decoction) compared to standard care in patients with COVID) -19, a multicenter open-labeled, randomized, controlled clinical trial) with the difference that in this study, the boiled medicine is given to the patients in the form of syrup and a quarter of the dose used in the previous study. Participants without underlying disease will use 10 cc of syrup every 12 hours. The study period will be 8 weeks. Syrup will be standardized based on total phenol. Intervention 2: Intervention group, strata 2: Participants with underlying disease will take one saffron capsule daily (standardized to 15 mg of crocin per capsule) every 12 hours. The study period will be 8 weeks. Intervention 3: Control group, strata 1: The syrup placebo will be prepared by water, sugar and food coloring completely similar to herbal syrup, and the participants will use 10 cc of syrup every 12 hours for 8 weeks. Intervention 4: Control group, strata 2: The placebo capsule will be filled with pectin and will look exactly the same as the intervention capsule, and the patients will use 1 capsule every 12 hours for 8 weeks.Primary outcome:
Dyspnea severity. Timepoint: Before treatment and after 4 and 8 weeks. Method of measurement: St George's Respiratory Questionnaire.;Cough severity. Timepoint: Before treatment and after 4 and 8 weeks. Method of measurement: St George's Respiratory Questionnaire.Criteria:
Inclusion criteria: Confirmation of mustard gas induced lung injury by a pulmonologistPrevious asthma
Seasonal Allergy
Acute respiratory infection
Smoking
Alcohol consuming
Exclusion criteria: Uncontrolled hypertension
Unwilling to participate
2.
IRCT; 2023-05-01; TrialID: IRCT20221207056741N1
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20221207056741N1
ABSTRACT
Condition:
COVID 19.Post Covid 19 Condition;U09.9
Intervention:
Intervention group: 1- Single task balance exercise 2- Dual task balance training group 3- Control group, In this research, the single task exercise group only practices balance exercises, while the dual task exercise group simultaneously performs cognitive activity at the same time as balance exercise. The control group in this research only participates in the pre-test and post-test..Primary outcome:
Berg Balance scale to measure functional balance status in elderly people. Timepoint: In this research, this variable will be taken from people 24 hours before the training phase and 24 hours after the end of the last training session. Method of measurement: This test consists of 14 sub-tests that will be administered by the examiner and higher scores in this test indicate higher functional balance. To perform this test, very simple devices such as a timer, a ruler, and a step with a height of 18 to 20 cm will be used.;People's reaction time in serial reaction time software to measure cognitive performance in elderly people. Timepoint: In this research, this variable will be taken from people 24 hours before the training phase and 24 hours after the end of the last training session. Method of measurement: In this test, the person must respond to the stimuli that are presented in a specific and predetermined pattern on the monitor screen as quickly as possible. For the answer, the person must press the desired key of each stimulus on the keyboard. Reaction time refers to the duration of the presentation of the stimulus until the response to it. Obviously, the faster a person responds, it shows the learning of the sequence and the better functioning of the central nervous and cognitive system of the person.;Gait speed in Timed Up And Go Test. Timepoint: In this research, this variable will be taken from people 24 hours before the training phase and 24 hours after the end of the last training session. Method of measurement: Timed Up And Go test will be used to measure gait speed. In this test, the person has to get up from a chair with a handle with a height of approximately 46 cm and a handle height of 65 cm, walk 3 meters, go around an obstacle, turn around and sit down. The person performs this test in two conditions with and without the cognitive task at the same time.;Measuring the psychological variable of fear of falling by Yardley et al.'s (2005) fear of falling scale. Timepoint: In this research, this variable will be taken from people 24 hours before the training phase and 24 hours after the end of the last training session. Method of measurement: This questionnaire contains 16 questions that people fill in two stages at the beginning and at the end of the training protocol. Higher scores in this test indicate greater fear of falling and lower self-efficacy.Criteria:
Inclusion criteria: Aging between 60-80Ability to stand for a minute and walk for 10 for 10 minutes without and aids and stick
Normal vision
Being able to read and write
Being healthy or not having used any balance affecting medicine
Having tested positive in COVID19 and being hospitalized in a recent year
Living in Kerman city
Scoring more than 24 points at Standardized Mini-Mental State Examination
Exclusion criteria: Progressive neurological condition such as Parkinson disease, or Alzheimer
Existence of cardiovascular disease (myocardial infarction, congestive heart disease, uncontrolled blood pressure, hypotension, decreased heart rate)
Significant visual and auditory impairments
History of depression, anxiety or other mental disorders
Having a history of rheumatic and metabolic diseases such as rheumatoid arthritis, diabetes
Existence of severe deformities of the joints of the lower limbs or trunk, such as severe Kyphosis or scoliosis, severe osteoarthritis of the hip and knee joints.
Having a history of balance disorder and frequent positional dizziness
Having a history of joint replacement in the lower limb
Consuming alcohol, sedatives or any type of special medicine that affects balance or cognitive status.
High inflammation of lungs up to 40% due to COVID 19
3.
IRCT; 2023-03-14; TrialID: IRCT20230305057618N1
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20230305057618N1
ABSTRACT
Condition:
COVID-19.Coronavirus infection, unspecified;B34.2
Intervention:
Intervention 1: Intervention group 1- Respiratory muscle training: They participate in a six-week training period. In addition to breathing training, these exercises include diaphragmatic breathing exercises, pursed lip breathing exercises, cough exercises, and stretching exercises. Exercises are done twice a week for one hour at home. Supervision of exercises is done through video and social networks. Intervention 2: Intervention group 2- Peripheral muscle training: They participate in a six-week training period. This course includes breathing, muscle, balance, aerobic and stretching exercises. Exercises are done twice a week for one hour at home. Exercises are done at home. Supervision of exercises is done through video and social networks. Intervention 3: Control group: The test group is asked not to participate in any exercise program during the research period and to continue their daily diet and to report any changes such as illness, stress, etc.Primary outcome:
Respiratory volumes. Timepoint: Before and after the intervention. Method of measurement: Plethysmography system.;Maximal inspiratory mouth pressures. Timepoint: Before and after the intervention. Method of measurement: Plethysmography system.;Maximal expiratory mouth pressures. Timepoint: Before and after the intervention. Method of measurement: Plethysmography system.;Maximal Voluntary Ventilation. Timepoint: Before and after the intervention. Method of measurement: Plethysmography system.;Diffusing capacity for carbon monoxide. Timepoint: Before and after the intervention. Method of measurement: Plethysmography system.;Ratio diffusing capacity for carbon monoxide to Alveolar Volume (DLCO/VA). Timepoint: Before and after the intervention. Method of measurement: Plethysmography system.Criteria:
Inclusion criteria: Pneumonia confirmed by Pulmonologist (having signs and radiographic evidence of pneumonia)Stable clinical condition
regular participation in the treatment process (before participating in the research)
Being interested in participating in training courses
Exclusion criteria: Pulmonary resection
Neurological disease
Mental illness
COPD disease
A history of orthopedic and neurological disease that prevents exercise
Uncontrolled blood pressure
Cardiovascular disease
Pregnancy and breastfeeding status
4.
IRCT; 2022-11-22; TrialID: IRCT20221006056103N1
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20221006056103N1
ABSTRACT
Condition:
Covid19.COVID-19, virus identified;U07.1
Intervention:
Intervention 1: Intervention group: After people are placed in the control and test groups, a demographic questionnaire is given to the samples of the test group using random allocation, and then after the first-degree family member who was responsible for taking care of the patient, it is determined that Using a health literacy questionnaire, the level of family health literacy in the test group is examined, and in the next step, using questionnaires to measure the delayed complications of Covid-19 patients, which includes the assessment of the patients' fatigue and shortness of breath, the basic condition of the test group samples. After the discharge of the patients in the test group, the care package according to the latest standard recipes and approved by the experts in this field is given to the same person from the family who takes care of the patient in a group method based on A family-oriented model will be presented. In the first step, meetings (usually the first and second meeting) with the aim of the perceived threat through increasing the level of knowledge and understanding about the problems threatening the patient, as well as the nature, complications, process, prognosis and symptoms of the disease will be held face to face and in person. At the end of the session, educational cards containing a summary of the topics raised in the sessions will be given to the participants to review the material. In the second step of the session, to solve the problems and problems of the patients, training on functional matters such as how to perform effective breathing, planning activity and rest periods, methods Correctly performing the activities and movements by the method of problem solving and group discussion and transfer of experiences will be done in the formPrimary outcome:
Tiredness. Timepoint: 7 and 42 days. Method of measurement: Fatigue Severity Scale Questionnaire.;Shortness of breath. Timepoint: 7 and 42 days. Method of measurement: Borg scale.Criteria:
Inclusion criteria: Criteria for inclusion in the study are patients with COVID-19 who have been admitted to hospital wards and have been diagnosed with COVID-19 through a positive PCR and CT Scan report.Patients should not have fever for 3 consecutive days at the time of discharge
Include level 2 and 3 patients of the classification of Covid 19 patients based on the instructions issued by the Ministry of Health
The patient's spo2 should be between 85 and 93 during discharge
Involvement of more than 50% in lung CT scan
During the clearance of inflammatory markers, the proportion of early stages has decreased
COVID 19 through positive PCR and CT Scan report..Patient caregiver inclusion criteria The patient's caregiver is the person with whom the patient lives and is responsible for taking care of the patient
The health literacy level of the patient's family member (participant) should be less than 66 based on the health literacy
Willingness to participate in the study
Having minimum literacy in reading and writing
The patient's caregiver should have the ability to learn and communicate effectively
Exclusion criteria: History of underlying disease such as lung disease, cardiac disorders, and skeletal-muscular disorders
5.
IRCT; 2022-07-07; TrialID: IRCT20210914052480N2
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20210914052480N2
ABSTRACT
Condition:
COVID-19.COVID-19, virus identified;U07.1
Intervention:
Intervention 1: Intervention group: The group receiving oral molnopiravir 200 mg daily for up to five days after the intervention, with diphenhydramine syrup / vitamin C tablet / vitamin D tablet / famotidine 40 mg tablet every 12 hours (in case of fever and pain Muscle naproxen 250 mg daily or twice daily will be added). Intervention 2: Control group: This group will receive placebo exactly similar to molnopiravir for five days, with diphenhydramine syrup, vitamin C tablets, vitamin D tablets, famotidine 40mg tablets every 12 hours, and naproxen 250 in case of fever and muscle aches. They will receive it once or twice a day.Primary outcome:
Negative pcr test or increase in CT NUMBER after intervention. Timepoint: Before and after the intervention. Method of measurement: According to the throat sample of patients with Covid-19, which is taken from patients in the same conditions in the specialized virology laboratory of Baqiyatallah Medical Center.;Fever. Timepoint: Upon arrival and after five days. Method of measurement: with a standard thermometer.;Serum CRP inflammatory factor. Timepoint: Upon arrival and after five days. Method of measurement: By a valid laboratory.;The level of oxygen saturation in the blood of patients. Timepoint: Upon arrival and after five days. Method of measurement: By standard pulse oximeter.;Dry cough existance. Timepoint: Upon arrival and after five days. Method of measurement: patient report and researcher observe.;Dyspnea. Timepoint: Upon arrival and after five days. Method of measurement: patient report and researcher observe.;Muscular pain. Timepoint: Upon arrival and after five days. Method of measurement: patient report and researcher observe.;Pulse rate. Timepoint: Upon arrival and after five days. Method of measurement: researcher measure.;Respiratory rate. Timepoint: Upon arrival and after five days. Method of measurement: researcher measure.;Blood pressure. Timepoint: Upon arrival and after five days. Method of measurement: researcher measure.;Serum ESR inflammatory factor. Timepoint: Upon arrival and after five days. Method of measurement: By a valid laboratory.Criteria:
Inclusion criteria: Living in a family with at least one infected person with COVID-19Not having pulmonary involvement
Not having symptoms like chest wall pain and dysnea suggesting pulmonary involvement
Positive PCR test of COVID-19
Patient with COVID-19 symptoms lesser than 3 days
Patients satisfied with consumption of oral medication
Blood oxygen saturation above 93 percents
Exclusion criteria: Patients under 18 years old
Having underlying diseases such as uncontrolled diabetes, uncontrolled blood pressure, liver and heart disease and kidney, heart and liver failure
History of any of the diseases including hepatitis B or C, HIV, autoimmune diseases and immunodeficiency
History of hepatocellular disease, liver failure and heart failure of liver tests more than 3 times normal
History of allergy to antiviral drugs
Existence of thrombocytopenia (platelets under 100000)
History of recent COVID-19 vaccination lesser than 7 days
being pregnant
breastfeeding
6.
IRCT; 2022-05-10; TrialID: IRCT20211116053079N1
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20211116053079N1
ABSTRACT
Condition:
covid-19.u07.1;covid-19,v
Intervention:
Intervention 1: Intervention group: In the intervention group, oxygen therapy is given in a targeted manner (spo2 = 92-93%) as a nasal catheter in the volume of 2-4 liters per minute and the blood oxygen saturation level is maintained in the range of 92-93% and in three times Before the intervention, 24 hours later and the time of discharge of the consequences is checked. The measurement method is pulse oximetry and is performed until the intervention clears. Intervention 2: Control group: In the control group, oxygen is routinely or non-purposefully delivered as a nasal catheter. (spo2> 96%) and in the three desired times upon arrival, 24 hours later, the time of discharge of the consequences is checked. The method of measurement is by pulse oximetry.Primary outcome:
SPo2. Timepoint: Upon arrival, 24 hours after, discharge. Method of measurement: Puls oximetry.Criteria:
Inclusion criteria: Patients with positive pcRPatients with mild lung involvement on CT scan
Patients with spo2 Less than 92%
Exclusion criteria: Failure to continue the intervention
Patients who become ill during the project.
Patients receiving ICU admission
7.
IRCT; 2021-12-23; TrialID: IRCT20210620051639N3
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20210620051639N3
ABSTRACT
Condition:
Covid 19.COVID 19, virus identified;U07.1
Intervention:
Intervention 1: Intervention Group: Injection of a dose of 80 micrograms of recombinant RBD protein vaccine intramuscularly (deltoid muscle) in 10000 participants in affiliated centers of Baqiyatallah Hospital and 200 participants in Shahid Soleimani Clinical Trial Center. Intervention 2: Control group: Injection of a placebo intramuscularly (deltoid muscle) in 100 participants in Shahid Soleimani Clinical Trial Center.Primary outcome:
?The level of specific IgG antibody against RBD protein in days 0 and 21 after booster injection based on GMI, GMT and seroconversion rate (increase at least 4 times in antibody titer) in Shahid Soleimani Clinical Trial Center (sample of 300 people). Timepoint: in days 0 and 21 after booster injection. Method of measurement: The level of specific IgG antibody against RBD protein ibased on GMI, GMT and seroconversion rate (increase at least 4 times in antibody titer) .;Cellular immune response to booster dose based on measurement of IL 4 and INF? levels using ELISA method on days 0 and 21 after injection (subgroup of 90 people). Timepoint: in days 0 and 21 after booster injection. Method of measurement: Cellular immune response to booster dose based on measurement of IL 4 and INF? levels using ELISA method .;Measurement of neutralizing antibody level by neutralization test method Virus (subgroup of 90 people). Timepoint: in days 0 and 21 after booster injection. Method of measurement: Measurement of neutralizing antibody level by neutralization test method Virus.Criteria:
Inclusion criteria: Age 18 years and olderCandidates who have received two identical doses of the available vaccine (Sinopharm, CovIran Barakat, AstraZenka) and at least 3 months (at least 90 days) have passed since the second dose
The candidate is able to fully understand the provisions of the informed consent form and sign it before entering the study
Exclusion criteria: SARS CoV 2 infection (clinically significant or rtPCR document)
Approved or suspected COVID 19 in the last two months
Going through home quarantine due to suspicion of having an exposure to a patient with Corona
History of severe allergic reactions
Chronic kidney, liver and various malignancies
Acute bacterial infection in the last 7 days
Known cases of immunodeficiency, HIV, or autoimmune diseases
Receiving immunosuppressive drugs or corticosteroids in the last 3 months
Receiving immunoglobulin or blood products during the three months prior to vaccination
Pregnant or Breastfeeding women or those who plan to become pregnant during the study period
8.
IRCT; 2021-10-11; TrialID: IRCT20210620051639N2
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20210620051639N2
ABSTRACT
Condition:
COVID-19.U07.1 COVID-19, virus identified;U07.1
Intervention:
Intervention 1: Intervention group: receiving 80 micrograms of RBD protein recombinant SARS-CoV-2 vaccine in days 0, 21, and 35; intramuscular (deltoid muscle). Intervention 2: Control group: the placebo group will receive an intramuscular injection (in the deltoid muscle) consisting of buffer and adjuvant only, on days 0, 21, and 35.Primary outcome:
IgG antibody against Receptor Binding Domain (RBD) protein. Timepoint: in days 0, 35, 49, 125, 215 after injection of the first dose of vaccine. Method of measurement: based on ELISA method and seroconversion rate (proportion of individuals with at least twofold and fourfold increases) and Geometric Mean Titer (GMT).;Cellular immunity response against recombinant vaccine RBD protein. Timepoint: in days 0 and 49 after injection of the first dose. Method of measurement: determining Th1 or Th2 dominance based on levels of IL-4? IL-10? IL-12? ? INF? with ELISA measurement, and levels of CD3? CD4? CD8 with INF? based on flow cytometry measurement.;Measurement of neutralizing Antibody based on virus neutralizing test (VNT). Timepoint: in day 49 after injection of the first dose. Method of measurement: Based on the cell culture and inhibition of virus entry (Neutralizing titer).Criteria:
Inclusion criteria: Healthy persons, 18-40 years old,Without uncontrolled underlying disease
Exclusion criteria: History of Covid-19 disease in the past month, positive coronavirus PCR test, uncontrolled underlying disease, T Important surgical history, receiving corona vaccine
9.
IRCT; 2021-08-23; TrialID: IRCT20180201038585N11
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20180201038585N11
ABSTRACT
Condition:
Covid-19.COVID-19, virus identified;U07.1
Intervention:
Intervention 1: Intervention group: At the beginning of the study, patients in the intervention group will receive 30-gram sachets of functional food (functional soup). Patients in the intervention group will be asked to consume a 30-gram packet of functional food (functional soup) daily in the morning for 1 week. In order to increase compliance, patients were asked on a daily basis. Intervention 2: Control group: Patients in the control group will receive 30-gram packages of regular food (barley soup) at the beginning of the study. Patients in the control group will be asked to consume a 30-gram packet of regular food (barley soup) daily in the morning for 1 week. In order to increase compliance, patients are asked on a daily basis.Primary outcome:
The amount of inflammatory and anti-inflammatory cytokines (Il-1ß? Il-6? TNFa?IL-10? IL-4 ,IFN? ). Timepoint: At the start and after 1 week of study. Method of measurement: Through intravenous blood samples and commercial kits.Criteria:
Inclusion criteria: The need for hospitalization with clinical signs in favor of coronavirus infection includes one or more of the following : The patient experiences a decrease in oxygen saturation of less than 93%A drop in systolic blood pressure less than 100 or a drop in blood pressure of 30 mm Hg from the patient's previous normal systolic pressure
fever
Dry cough
the positive result of CRP index
Laboratory indexes included : CRP , ESR
Exclusion criteria: Patient dissatisfaction
Lack of proper conditions for oral feeding
10.
IRCT; 2021-06-25; TrialID: IRCT20210620051639N1
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20210620051639N1
ABSTRACT
Condition:
COVID-19.COVID-19, virus identified;U07.1
Intervention:
Intervention 1: Intervention group: receiving 80 micrograms of RBD protein recombinant SARS-CoV-2 vaccine in days 0, 21, and 35; intramuscular (deltoid muscle). Intervention 2: Intervention group: receiving 120 micrograms of RBD protein recombinant SARS-CoV-2 vaccine in days 0, 21, and 35; intramuscular (deltoid muscle). Intervention 3: Control group: the placebo group will receive an intramuscular injection (in the deltoid muscle) consisting of buffer and adjuvant only, on days 0, 21, and 35.Primary outcome:
Any immediate adverse reaction after inoculation. Timepoint: 30 min after injection. Method of measurement: close monitoring.;Any local adverse events. Timepoint: 0-7 days after each injection. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.;Any systemic adverse events. Timepoint: 0-7 days after each injection. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.;Any laboratory adverse events. Timepoint: 0-7 days after each injection. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.;Any serious adverse events. Timepoint: 0-7 days after each injection. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.;Any serious adverse event, medically attended adverse event, or adverse event of interest. Timepoint: 0-125 days after each injection. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.Criteria:
Inclusion criteria: Age between 18 and 50 years oldHealthy in terms of past medical history, physical examination, and laboratory data-
Body mass index: 17-35 kg/m2
Willingness to participate in the study and complete follow-up
Ability to comprehend study methodology
Ability to comprehend and sign informed consent-
Provision of consent to access medical documents in case of contracting COVID-19
For women: negative pregnancy screening
Acceptance of contraception use from 21 days before randomization until six months after receiving the last vaccine dose
Acceptance of not receiving blood product or bone marrow from randomization until three months after receiving last vaccine dose
Exclusion criteria: Positive COVID-19 PCR test
Positive antibodies against SARS-CoV-2 (IgG, IgM)
History of infection with SARS-CoV-2 documented with RT-PCR test
Close contact with COVID-19 infected individual in the past 14 days
Isolation due to signs and symptoms that are suspicious of COVID-19
Fever (axillary temperature > 37° C), dry cough, fatigue, nasal congestion, rhinorrhea, sore throat, myalgia, diarrhea, dyspnea in the past 14 days
Laboratory abnormalities in biochemistry profile, blood, and urine (including urea, creatinine, fasting blood sugar, Na, K, aspartate transaminase, alanine transaminase, alkaline phosphatase, total bilirubin, hemoglobin, leukocyte count, neutrophil count, lymphocyte count, platelet count, urine protein, urine glucose, blood cells in urine)
History of severe allergic reactions or allergy to vaccine components (latex)
Experience to severe allergic or allergic reactions to components of the recombinant RBD protein vaccine (latex sensitivity)
Personal or family history of seizure, epilepsy, encephalopathy, psychiatric disorder
Congenital malformations
-History of neurologic diseases or seizure (except for febrile seizure at childhood)
Growth disorders
Genetic disorders
Malnutrition
Renal or liver abnormalities
Uncontrolled hypertension (>140/90 mmHg)
Heart failure with NYHA class =2
Recent exacerbations of cardiovascular disease include cardiovascular intervention, the addition of new cardiovascular drugs to control symptoms, or unstable angina.
Chronic obstructive lung disease with GOLD score =2-
Asthma
Diabetic complications
BMI > 35 kg/m2
History of malignancy in the past five years
Exacerbation of chronic diseases in the past 7 days
Immunodeficiency, lymphoma, leukemia, autoimmune diseases
Thyroid disease or history of thyroidectomy without proper control
Splenectomy or history of resection of solid organs
Coagulation abnormalities
Anti-tuberculosis treatment
Positive HBSAg
Positive HIV Ab
Positive HCV Ab
Receiving immunosuppressive therapy for 14 consecutive days in the past 3 months or need for such therapy in the following 6 months
Receiving any off-label or investigational therapy for COVID-19
Receiving flu vaccine in the past 14 days or other vaccines in the past 4 weeks
History of drug or alcohol abuse in the prior year
Receiving immunoglobulin or blood products in the prior 3 months
Receiving investigational drugs in the past 45 days
Planning to receive other vaccines in the next month
Severe psychiatric disorders interfering with participation in the trial
Women with positive beta-HCG, pregnancy, or during breastfeeding, or plan to become pregnant during the study
High risk occupation for COVID-19 exposure (health care workers) or with decision of investigators
First degree family members of the trial personnel
Any other reason that the investigators document making volunteers ineligible-
11.
IRCT; 2021-04-12; TrialID: IRCT20210325050769N1
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20210325050769N1
ABSTRACT
Condition:
COVID-19.COVID-19, virus identified;U07.1
Intervention:
Intervention 1: Intervention group: The drug (including tea, honey and royal jelly for 5 days) is delivered to the hospital along with the list of codes of patients in the intervention group (to be presented to patients in the intervention group).The composition inside each CRSM-X7 tea bag includes 10 grams of marshmallow, 5 grams of Sweet violet, 5 grams of Wild mallow, 5 grams of Damask rose, 10 grams of Liquorice root. After identification and registration, they will be placed in special bags for use. Each bag of CRSM-X7 herbal tea is infused in a volume of 300 ml of boiling water for one day use. After the temperature of the drink is reduced (it reached the temperature of 40 ° C), 5 cc of lavender honey is added, dissolved in it and drunk. So that, three glasses (each glass is equivalent to 100 ml) will be drunk per day (half an hour before breakfast, one hour before lunch, one hour before bedtime) up to five days by the intervention group. The seventh element of this supplement is Royal Jelly, which is prepared in the proportion of 50 grams of Royal Jelly in one kilo gram of lavender honey and should be used by the people under study 4 meals a day, ie morning, noon, evening, night for 5 days (each Promise of 2.5 cc). Intervention 2: Control group: Control group: 92 people are in the control group, which includes other patients and hospitalized in the same treatment center who receive a standard treatment regimen similar to the intervention group.Primary outcome:
Hospitalization time. Timepoint: Before starting the study and after 5 days of using herbal supplements. Method of measurement: A researcher-made questionnaire whose validity and reliability have been assessed.Criteria:
Inclusion criteria: Diagnosis of COVID-19Age 18-65
Having informed and written consent to participate in the study
Exclusion criteria: Disagreement of the physician directly responsible for the patient
Pregnancy and breastfeeding
Allergies to the drug elements
Symptoms of gastrointestinal, liver or kidney disease
Incidence of drug interactions
Patient dissatisfaction to continue the project for any reason
Inability of the patient to receive oral medication
Hypertension
Having heart failure
Do not take anticoagulants (aspirin, Plavix, warfarin)
12.
IRCT; 2021-02-13; TrialID: IRCT20210205050247N1
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20210205050247N1
ABSTRACT
Condition:
olfactory loss.Other disturbances of smell and taste;R43.8
Intervention:
Intervention 1: Intervention group: This group will be treated with respiratory physiotherapy or olfactory rehabilitation for 12 weeks. Intervention 2: Intervention group: The second group will be treated with vitamin A tablets (10,000 units per day) along with the olfactory rehabilitation method for 12 weeks. Intervention 3: Control group: The third group of patients will not receive any treatment intervention and these patients will be followed up for 12 weeks.Primary outcome:
Smell Identification. Timepoint: The olfactory test is performed for 12 weeks, twice a day, each time inhaling each odor for 10 seconds. Method of measurement: Aromatic kit that includes 4 main scents (eucalyptus, lemon, rose and Dianthus).Criteria:
Inclusion criteria: Age between 20 and 65No underlying disease including: hypertension, hypo and hyperthyroidism, seizures, diabetes, asthma, Bell's palsy
Continuation of olfactory reduction for more than two weeks
Exclusion criteria: Patient dissatisfaction
Prolonged exposure to some chemicals agents (detergents)
History of head trauma
History of sinus surgery or septorhinoplasty, rhinoplasty, turbinectomy and radiation therapy
Having neurodegenerative disease (Alzheimer's, Parkinson, MS, epilepsy, seizures)
Having mental disorders (schizophrenia and depression)
Having neuropsychiatric disorders (autism, Asperger's, lack of concentration and hyperactivity)
History of repeated use of the following drugs:Metronidazole, benzocaine, clofibrate, amphotericin B, ampicillin, allopurinol, captopril, baclofen, codeine, carbamazepine and amphetamines.
13.
IRCT; 2021-01-12; TrialID: IRCT20200318046812N3
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20200318046812N3
ABSTRACT
Condition:
COVID-19.COVID-19, virus identified;U07.1
Intervention:
Intervention 1: ''Intervention group:'' In this group, probiotics are given to the patients' families. Biomus supplement consists of 12 essential vitamins and minerals along with probiotics (a mixture of three native Iranian strains including Lactobacillus casei, L. rhamnosus and L. helveticus ). All these items are prepared in one capsule to strengthen the immune system and digestive system against viral and bacterial diseases.Three capsules of medicine/placebo are delivered daily to the participants after receiving informed consent and the eligibility of the cluster at the initial visit. In follow-up visits, after receiving the previous drug pack/placebo, the new treatment is sent to the patient's family using a courier. The amount of medicine/placebo delivered is enough until the next visit. Intervention 2: ''Control group'': Placebo is given to patients three times a day.Primary outcome:
?S?everity of cough. Timepoint: The variable in the drug and placebo groups can be recorded at the end of the first, second and fourth weeks. Method of measurement: Telephone followup.;?Severity of shortness of breath. Timepoint: The variable in the drug and placebo groups can be recorded at the end of the first, second and fourth weeks. Method of measurement: Telephone followup.Criteria:
Inclusion criteria: Confirmation of infection by PCR in a family memberInformed written consent
Living in Tehran
Number of family members between 2 and 5
Age between 18 to 63 years
No prognostic signs of Covid-19 disease two weeks before enrollment
Exclusion criteria: Not participating in another clinical trial in the last three months
Do not use other supplements (containing vitamins, minerals, and probiotics)
No documented history of Covid-19 infection in healthy family members
Pregnancy / breastfeeding
Drug sensitivity to the compounds in the intervention
Temporary residence or immigration and consecutive relocation from Tehran
Use similar supplements
14.
IRCT; 2021-01-11; TrialID: IRCT20201223049816N1
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20201223049816N1
ABSTRACT
Condition:
covid-19.COVID-19;U07.1
Intervention:
Intervention 1: Intervention group: 1. Phr-160 spray group: PHR spray:160 micrograms per puff, 1 puff every 1 hour up to ten times a day, on days 1 to 10 (use of Damir is required) in addition to the latest covid-19 treatment in the country protocol. Due to the clinical symptoms, this treatment protocol can be continued for 10 days if needed. Intervention 2: Control group: Standard emergency treatment based on protocol, Naproxen 250 mg , Famotidine 40 mg , Vitamin C 500 mg.Primary outcome:
Percentage of oxygen saturation in two intervention groups after randomization. Timepoint: 1. After randomization at the beginning of the patient's arrival, and every day. Method of measurement: Using Pulse Oximeter.Criteria:
Inclusion criteria: Both sexesAges 15-75
Oxygen saturation percentage between 88 and 93%.
Confirmation of 19 patients using RTPCR.
Confirmation of Covid-19 using CT scan
Signing a informed consent form
Exclusion criteria: Attending another trial in the last three months
pregnancy/lactation
drug sensitivity to the ingredients in the intervention
very high severity of the disease in the emergency room (consciousness less than 15 / oxygen concentration less than 88%, etc)
history of chronic respiratory disease
Previous pulmonary embolism (last three months)
15.
IRCT; 2020-11-08; TrialID: IRCT20200731048257N1
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20200731048257N1
ABSTRACT
Condition:
COVID-19.COVID-19, virus identified;U07.1
Intervention:
Intervention 1: Intervention group: : Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days / 25 mg prednisolone daily for 5 days / PHR160 spray one hour oral puff with Demyar ten times a day for ten days in a row, for ten days. Intervention 2: Control group: Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days Daily / 25 mg prednisolone daily for 5 days / placebo spray one hourly oral puff ten times a day for ten days in a row, for ten days.Primary outcome:
Dyspnea. Timepoint: The beginning of the study and the fifth day. Method of measurement: shortness of breath measured by Visual analog scale (VAS) dyspnea score. The minimum score is zero means shortness of breath and the highest score is 10 means the maximum intensity of shortness of breath.Criteria:
Inclusion criteria: informed consent to participate in the studyPatients 18 to 75 years of age with COVID-19 who have been diagnosed with PCR
Strong clinical suspicion of covid 19 with positive findings in CT Scan
Shortness of breath
Exclusion criteria: Patients with HIV
Patients with cancer undergoing chemotherapy
Patients receiving Immune Mediators
Patients need hospitalization in the intensive care unit
Patients with uncontrolled heart, kidney or liver failure
Pregnant or lactating women
Intolerance to the drugs used in this study (symptoms such as diarrhea, nausea, vomiting and respiratory problems)
16.
IRCT; 2020-10-22; TrialID: IRCT20080901001165N63
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20080901001165N63
ABSTRACT
Condition:
COVID-19.Covid-19;U07.1
Intervention:
Intervention 1: Intervention group: Myrtus nasal spray 1 puff into each nostril every 8 hours, for 14 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus). Intervention 2: Control group: Routine treatment according to the latest national guideline for the treatment of new corona-virus.Primary outcome:
Clinical symptoms (dry cough). Timepoint: Baseline (before the initiation of intervention), and day 7 from the initiation. Method of measurement: Physical examination,questionnaire.;Clinical symptoms (respiratory distress). Timepoint: Baseline (before the initiation of intervention), and day 7 from the initiation. Method of measurement: Pulse-oxymetery device.;Clinical symptoms (fever). Timepoint: Baseline (before the initiation of intervention), and day 7 from the initiation. Method of measurement: Thermometer.Criteria:
Inclusion criteria: Age: equal or more than 18 years;The patient have written consciously and freely consent to participate in the study;
The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19.
Confirmed diagnosis of COVID-19, with RT-PCR confirmation.
Less than 7 days have passed since the onset of symptoms.
Exclusion criteria: History of allergy to this nasal spray ingredients;
The patient is in another clinical trial at the same time;
The patient needs to receive medical care from the inpatient care;
Pregnancy;
Lactation.
17.
IRCT; 2020-09-08; TrialID: IRCT20160131026298N6
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20160131026298N6
ABSTRACT
Condition:
COVID-19.U07.2 COVID-19, virus not identified, COVID-19;U07.2
Intervention:
Intervention 1: Intervention group: Intervention groups will be two ones. Patients in the intervention group will receive the intervention drug (three capsules a day and ten grams of black seed mixture daily) that is made by Talaye sabze tooba company; in addition to the routine treatment (Azithromycin 250 mg daily for 10 days and Naproxen 250 mg twice a day for 10 days) . Intervention 2: Control group: The control group will receive the routine treatment (Azithromycin 250 mg daily for 10 days and Naproxen 250 mg twice a day for 10 days) .Primary outcome:
Measurement of cough severity. Timepoint: Day 1 before and at the end of treatment. Method of measurement: Cough scoring form.;Severity of shortness of breath. Timepoint: Day 1 before and at the end of treatment. Method of measurement: Shortness Of Breath With Daily Activity (SOBDA) Questionnaire.;Lung radiologic changes. Timepoint: At beginning and end of the study. Method of measurement: Chest CT scan.Criteria:
Inclusion criteria: Male or female patients 18 years old and older with Coronavirus Disease 2019 (COVID-19)Ground glass view at low-dose CT scan
Consciously completed consent form completed by the patient or the patient's supervisor
Exclusion criteria: History of pulmonary malignancy
History of asthma or COPD
History of Disabling disease or malignancy
Liver or kidney disorders
18.
IRCT; 2020-08-04; TrialID: IRCT20160131026298N4
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20160131026298N4
ABSTRACT
Condition:
COVID-19 viral disease.Coronavirus infection, unspecified;B34.2
Intervention:
Intervention 1: Intervention group: Consumable product includes herbal syrup composed of cyclopeptide fraction with Ziziphus spina-cristi and Pimpinela anisum hydroalcoholic extract and orange peel. The dose of the product is 20 ml every 8 hours after eating, which is prepared by Herbi Pharmed Pharmaceutical Company. Intervention 2: Control group: do not use any drugs for prevention and only follow health protocols to prevent infection.Primary outcome:
Polymerase chain reaction (PCR) analysis result. Timepoint: At the beginning of the intervention and the day 14. Method of measurement: Polymerase chain reaction (PCR) analysis.;Liver function test result. Timepoint: At the beginning of the intervention and the day 14. Method of measurement: Measurement of aspartate aminotransferase (AST) and Alanine transaminase (ALT) factors.;Fragment D-dimer test result. Timepoint: At the beginning of the intervention and the day 14. Method of measurement: Blood test - Fragment D-dimer measurement.;Measurement of serum iron. Timepoint: At the beginning of the intervention and the day 14. Method of measurement: Blood test - Total iron binding capacity factor (TIBC) measurement.;COVID-19 Antibodies. Timepoint: At the beginning of the intervention and the day 14. Method of measurement: Measurement of IgG COVID-19 and IgM COVID-19 factors.Criteria:
Inclusion criteria: People over the age of 18 who have had close contact with a person with COVID-19 in the last 4 days and signed an informed consent form (close contact is defined as those who live at home with an infected person or depending on their employment situation in Less than two meters away from the infected person.) And have no previous or current history of COVID-19.Age between 18 and 70 years
No previous diagnosis of COVID-19 (if possible, test negative for IgG and IgM antibodies.)
Absence of symptoms such as fever, body aches, olfactory and taste disturbances, cough, shortness of breath, diarrhea in the last 1 month
Exclusion criteria: Current incidence of COVID-19 is confirmed by PCR and clinical signs.
History of autoimmune disease
History of rheumatic disease
Pregnancy and lactation
Age under 18 years
People sensitive to any component of the product
People who can not follow up.
Any clinical reason that may prevent you from entering the study.
Do not take two doses of the drug
19.
IRCT; 2020-06-18; TrialID: IRCT20171105037262N4
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20171105037262N4
ABSTRACT
Condition:
COVID-19.COVID-19, virus identified;U07.1
Intervention:
Intervention 1: Intervention group: 50 patients with COVID-19 who receive routine antiviral treatment and chloroquine, have more than normal levels of TNF-a, and are at risk of critical disease statement (1-respiratory failure that needs mechanical ventilation, 2-shock, 3-any organ failure, 4-need to be admitted in ICU) will receive subcutaneous injection of anti-TNF-a (adalimumab), 40 mg, in periumbilical region of the abdomen. According to altered clinical and laboratory findings, mentioned dose can be repeated. Intervention 2: Control group: 50 matched patients receiving equal antiviral treatment and chloroquine.Primary outcome:
Disease severity. Timepoint: At the beginning and end of the intervention. Method of measurement: According to protocol and clinical symptoms.Criteria:
Inclusion criteria: Having COVID-19Respiratory distress with over 30 breaths per minute
O2 saturation less than 93% at rest
PaO2/Fio2 less than 300 mmHg
HRCT indicating COVID-19
positive PCR test result
Exclusion criteria:
20.
IRCT; 2020-05-28; TrialID: IRCT20080901001165N60
Clinical Trial Register
| ICTRP | ID: ictrp-IRCT20080901001165N60
ABSTRACT
Condition:
COVID-19.Covid-19;U07.1
Intervention:
Intervention 1: Intervention group: Provita Capsule (each capsule contain vitamin A, E, D, C, B family, Zn, Se, Para-biotic, and inactive ingredients, produced by Tak-Gen-Zist pharmaceutical company, Iran) 1 capsule, every 12 hours, for 21 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus). Intervention 2: Control group: Placebo Capsule(contain inactive ingredients similar to Provita's inactive ingredients, produced by Tak-Gen-Zist pharmaceutical company, Iran), 1 capsule, every 12 hours, for 21 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus.).Primary outcome:
Clinical symptoms (dry cough). Timepoint: Daily monitoring at the hospitalization, but the result of baseline (before the initiation of intervention), and day 7 and day 21 from the initiation, is recorded. Method of measurement: Physical examination,questionnaire.;Clinical symptoms (respiratory distress). Timepoint: Daily monitoring at the hospitalization, but the result of baseline (before the initiation of intervention), and day 7 and day 21 from the initiation, is recorded. Method of measurement: Pulse-oxymetery device.;Clinical symptoms (fever). Timepoint: Daily monitoring at the hospitalization, but the result of baseline (before the initiation of intervention), and day 7 and day 21 from the initiation, is recorded. Method of measurement: Thermometer.Criteria:
Inclusion criteria:Age: equal or more than 18 years;
The patient have written consciously and freely consent to participate in the study;
The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19.
Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation.
Less than 7 days have passed since the onset of symptoms.
Exclusion criteria:
History of allergy to the ingredients;
The patient is in another clinical trial at the same time;
The patient needs to receive medical care from the intensive care unit;
Pregnancy;
Lactation.
Impossibility of oral nutrition;