Providing Diabetes Education through Phone Calls Assisted in the Better Control of Hyperglycemia and Improved the Knowledge of Patients on Diabetes Management.

Purpose: A recent single-arm pilot study from our group showed a significant decrease in HbA1C in Type-2 diabetes individuals provided with SMS and phone call-based education on glycemic control. Considering the preference of participants to phone call-based education, a randomized control trial (RCT) with parallel design was conducted to determine the impact of phone call-based diabetes educational intervention on the control of hyperglycemia and improvement in the knowledge about diabetes management. Objectives: To determine the impact of phone call-based educational intervention on the control of hyperglycemia and improvement in the knowledge about diabetes management. Methodology: The study was conducted for a period of 12 months on a total of 273 Type-2 diabetic patients (interventional group (n = 135); non-interventional group (n = 138)) who had provided consent to participate. Subjects in the case group received weekly phone calls on diabetes education; whereas the control group received no education. HbA1C investigations were carried out at baseline and at every fourth month until the completion of the study period for the subjects in both the groups. The impact of phone call-based education was measured by comparing HbA1C values as well as by measuring the questionnaire-based knowledge scores on diabetes management. Results: At the end of the study period, there was a significant reduction in HbA1C in 58.8% participants (n = 65) and a manifold (2-5-fold) increase in knowledge on diabetes management among participants in the case group (n = 110). However, no significant difference in HbA1C and knowledge score was observed in participants from the control group (n = 115). Conclusion: Phone call-based diabetes education is a viable option to empower patients for better management of Type-2 diabetes.

Safety and efficacy of a Siddha Medicine fixed regimen for the treatment of asymptomatic and mild COVID-19 patients.

Background: The Coronavirus disease 2019 (COVID-19) pandemic caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is a massive threat to public health worldwide. Siddha system of medicine is one of the traditional medicines of South India. The recommended formulations in Siddha Sasthric Medicines- Fixed Regimen (SSM-FiRe) are Amukkura tablets, Kaba Sura Kudineer (KSK) for asymptomatic COVID-19 positive (RT-PCR) patients, and Athimathuram tablets, Adathodai Manappagu syrup, Thippili Rasayanam, Brahmananda Bairavam tablet, and Notchi Kudineer for mild symptomatic patients. The core objective of the trial was to document the efficacy of SSM-FiRe in the prevention of asymptomatic and mild COVID-19 disease progression to the next level of severity, reduce the severity of symptoms and revert to RT-PCR Negative. Methods: An exploratory, prospective, open-labeled, single-arm, non-randomized trial was designed as per GCP guidelines to assess the efficacy of SSM-FiRe. Sixty RT-PCR positive participants who were asymptomatic or with mild COVID-19 symptoms were recruited for the study at the Siddha COVID Care Centre, Vyasarpadi, Chennai from June to August 2020. Nasal and oropharyngeal swab tests were performed on the 0, 7th, and 14th days. All participants were treated with SSM - FiRe regimen. All the participants were also assessed based on Siddha Yakkkaiyin Ilakkanam, which included Clinical symptoms and vitals. Laboratory investigations such as Haemogram, Liver Function Test, Renal Function Test, HbA1C, Electrolytes, Inflammatory markers, Cardiac profile, Immunoglobulins, and anti-SARS-CoV-2 antibody tests were performed. Results: 83% of COVID-19 patients turned RT-PCR negative on the 7th day and in most of the cases, symptoms were reduced within the first 5 days of admission. The RT-PCR cycle threshold (ct) value increased significantly (<0.001) after treatment and all the participants were RT-PCR negative, except one, who was positive even after 14 days. Anti-SARS-CoV-2 antibodies developed significantly (p-value - 0.006). LFT, RFT, CBC, Total proteins, and electrolytes continued to be in the normal range after treatment, indicating the safety of the intervention. Conclusion: Asymptomatic and mild COVID-19 disease can be well managed by SSM - FiRe treatment, Further studies could be taken up to strengthen the findings.

In Silico computational screening of Kabasura Kudineer - Official Siddha Formulation and JACOM against SARS-CoV-2 spike protein.

BACKGROUND: Siddha Medicine is a valuable therapeutic choice which is classically used for treating viral respiratory infections, this principle of medicine is proven to contain antiviral compounds. OBJECTIVE: The study is aimed to execute the In Silico computational studies of phytoconstituents of Siddha official formulation Kabasura Kudineer and novel herbal preparation - JACOM which are commonly used in treating viral fever and respiratory infectious diseases and could be affective against the ongoing pandemic novel corona virus disease SARS-CoV-2. METHOD: Cresset Flare software was used for molecular docking studies against the spike protein SARS-CoV-2 (PDB ID: 6VSB). Further, we also conducted insilico prediction studies on the pharmacokinetics (ADME) properties and the safety profile in order to identify the best drug candidates by using online pkCSM and SwissADME web servers. RESULTS: Totally 37 compounds were screened, of these 9 compounds showed high binding affinity against SARS-CoV-2 spike protein. All the phytoconstituents were free from carcinogenic and tumorigenic properties. Based on these, we proposed the new formulation called as "SNACK-V" CONCLUSION: Based on further experiments and clinical trials, these formulations could be used for effective treatment of COVID-19.

Kabasura Kudineer (KSK), a poly-herbal Siddha medicine, reduced SARS-CoV-2 viral load in asymptomatic COVID-19 individuals as compared to vitamin C and zinc supplementation: findings from a prospective, exploratory, open-labeled, comparative, randomized controlled trial, Tamil Nadu, India.

INTRODUCTION: Despite several ongoing efforts in biomedicine and traditional medicine, there are no drugs or vaccines for coronavirus disease 2019 (COVID-19) as of May 2020; Kabasura Kudineer (KSK), a polyherbal formulation from India's Siddha system of medicine, has been traditionally used for clinical presentations similar to that of COVID-19. We explored the efficacy of KSK in reducing viral load and preventing the disease progression in asymptomatic, COVID-19 cases. METHODS: A prospective, single-center, open-labeled, randomized, controlled trial was conducted in a COVID Care Centre in Chennai, India. We recruited reverse-transcription polymerase chain reaction (RT-PCR)-confirmed COVID-19 of 18 to 55 years of age, without clinical symptoms and co-morbidities. They were randomized (1:1 ratio) to KSK (60 mL twice daily for 7 days) or standard of care (7 days supplementation of vitamin C 60,000 IU morning daily and zinc 100 mg evening daily) groups. The primary outcomes were reduction in the SARS-CoV-2 load [as measured by cyclic threshold (CT) value of RT-PCR], prevention of progression of asymptomatic to symptomatic state, and changes in the immunity markers including interleukins (IL-6, IL-10, IL-2), interferon gamma (IFNγ), and tumor necrosis factor (TNF α). Siddha clinical assessment and the occurrence of adverse effects were documented as secondary outcomes. Paired t-test was used in statistical analysis. RESULTS: Viral load in terms of the CT value (RdRp: 95% CI = 1.89 to 5.74) declined significantly on the seventh day in the KSK group and that of the control group, more pronounced in the study group. None progressed to the symptomatic state. There was no significant difference in the biochemical parameters. We did not observe any changes in the Siddha-based clinical examination and adverse events in both groups. CONCLUSION: KSK significantly reduced SARS-CoV-2 viral load among asymptomatic COVID-19 cases and did not record any adverse effect, indicating the use of KSK in the strategy against COVID-19. Larger, multi-centric trials can strengthen the current findings. TRIAL REGISTRATION: Clinical Trial Registry of India CTRI2020/05/025215 . Registered on 16 May 2020.

Analysis of AYUSH studies registered in clinical trials registry of India from 2009 to 2020.

BACKGROUND: The Clinical Trials Registry-India (CTRI) is an initiative of the Indian Council of Medical Research, New Delhi, India (ICMR) and monitored by the ICMR-National Institute of Medical Statistics (NIMS) since July 20, 2007. Randomized clinical trials are considered as the gold standard in evidence-based medicine. Registration of clinical trials enables disseminating evidence among clinicians, researchers, and patients. It promotes transparency and avoids duplication. The registration process is mandatory for AYUSH clinical trials also. OBJECTIVES: This analysis is aimed to determine the different characteristics of registered AYUSH clinical trials in CTRI from 2009 to 2020. MATERIALS AND METHODS: A cross-sectional retrospective analysis was conducted. The information on registered clinical trials about AYUSH was obtained from the website www.ctri.nic.in from 2009 to 2020 (n = 3632; last accessed on July 30 2020). Data analysis considered the following factors for analysis using descriptive statistics. The number of clinical trials registered in AYUSH stream were classified according to registration type (retrospective/prospective), postgraduate dissertations (yes/no), primary sponsor, type of trial (interventional/observational), study design, health condition and State-wise distribution of sites of studies. RESULTS: The number of clinical trial registrations among AYUSH streams (3632) descends from Ayurveda (2054), followed by Siddha (635), Yoga (408), Unani (366) and Homoeopathy (169). Interventional studies dominate observational studies among all AYUSH registered trials. AYUSH streams took four years to register in CTRI due to an increase in reporting trials from 2013. Significant number of trials were registered retrospectively. The order of closure of retrospective registration has influenced an increase in prospective enrolment between 2017-2019. CONCLUSION: Registration of clinical trials in the CTRI should be encouraged. Randomized controlled trials (RCTs) occupy a rear seat which exposes an opportunity for trials and alarms about weak trials. Non-communicable diseases (NCDs) are registered more comparatively, which reflects the strength of AYUSH in NCDs. Most of the trials fall under phase 2, which seems to have an increasing opportunity for more trials. Certain visible flaws like registering Phase 2 trials as Phase 3 or 4 and domestic trials as international trials reflect human resources crunch in ICMR-CTRI in Issuing Certificates. These errors should be rectified by training the stakeholders effectively.

Intervention through Short Messaging System (SMS) and phone call alerts reduced HbA1C levels in ~47% type-2 diabetics-results of a pilot study.

PURPOSE: Despite extensive research and newer methods of interventions, the incidence and prevalence of diabetes is increasing at an alarming rate. Currently, according to world health organization (WHO) statistics, 422 million individuals are suffering from diabetes worldwide. In India, recent estimates have reported a significant increase in the number of diabetics in the last decade. Poor dietary habits, minimal adherence to treatment regimens, lack of timely education are some of the contributing factors for increasing incidence and huge economic burden; which can be handled by life style behavior modifications backed up by hand holding through continuous education. Prior studies have demonstrated the efficacy of various self-management tools and educational programs in better disease management behaviors among individuals with diabetes. Among various self-management tools, educating the individuals and alerting them using mobile phone calls and short messaging system (SMS) are widely accepted due to (a) the increasing mobile phone users and (b) availability of short messaging systems in local languages in the recent years. Therefore, a pilot study was conducted to determine the benefit of educating patients through phone calls and SMS in the self-management of diabetes. OBJECTIVES: The objective of the study is to determine the feasibility and utility of SMS and phone call-based interventions in the management of diabetes by comparing the HbA1c values. METHODOLOGY: The study was conducted for a period of 14 months from December 2017 till Feb 2019. Out of 380 individuals initially enrolled into the study, 120 had completed the 14-months period. Diabetes education through SMS and phone calls was provided on regular basis, and HbA1C levels at baseline, 8-months and 14-months quantified. In addition, feedback on patients' satisfaction and utility of the SMS / Phone calls was collected using questionnaires. RESULTS: Data from our study demonstrated that after 8-months of intervention through phone calls, a significant increase in the number of individuals with HbA1c in the range of 5.1 to 7.0 was observed (from 27 individuals at base line to 37 individuals after 8-months intervention). Much more significant improvement in the number of individuals with lower HbA1c was observed at 14-months of intervention, indicating the benefit of regular phone call-based system in managing diabetes. A Chi square (χ2) test was performed to examine if the frequencies in the cells varied at baseline and at 8 and 14 months. CONCLUSION: Chronic diseases like diabetes needs awareness and education to patients in adopting disease self-management practices. As mobile phone users are increasing in number, providing diabetes management education through mobile phone intervention could be a viable strategy for controlling diabetes.

The efficacy of Siddha Medicine, Kabasura Kudineer (KSK) compared to Vitamin C & Zinc (CZ) supplementation in the management of asymptomatic COVID-19 cases: A structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: The primary objectives of this study are to determine efficacy of Siddha medicine, Kabasura kudineer in reduction of SARS-CoV-2 viral load and reducing the onset of symptoms in asymptomatic COVID-19 when compared to Vitamin C and Zinc (CZ) supplementation. In addition, the trial will examine the changes in the immunological markers of the Siddha medicine against control. The secondary objectives of the trial are to evaluate the safety of the Siddha medicine and to document clinical profile of asymptomatic COVID-19 as per principles of Siddha system of Medicine. TRIAL DESIGN: A single centre, open-label, parallel group (1:1 allocation ratio), exploratory randomized controlled trial. PARTICIPANTS: Cases admitted at non-hospital settings designated as COVID Care Centre and managed by the State Government Stanley Medical College, Chennai, Tamil Nadu, India will be recruited. Eligible participants will be those tested positive for COVID-19 by Reverse Transcriptase Polymerase Chain reaction (RT-PCR) aged 18 to 55 years without any symptoms and co-morbidities like diabetes mellitus, hypertension and bronchial asthma. Those pregnant or lactating, with severe respiratory disease, already participating in COVID trials and with severe illness like malignancy will be excluded. INTERVENTION AND COMPARATOR: Adopting traditional methods, decoction of Kabasura kudineer will be prepared by boiling 5g of KSK powder in 240 ml water and reduced to one-fourth (60ml) and filtered. The KSK group will receive a dose of 60ml decoction, orally in the morning and evening after food for 14 days. The control group will receive Vitamin C (60000 IU) and Zinc tablets (100mg) orally in the morning and evening respectively for 14 days. MAIN OUTCOMES: The primary outcomes are the reduction in the SARS-CoV-2 load [as measured by cyclic threshold (CT) value of RT-PCR] from the baseline to that of seventh day of the treatment, prevention of progression of asymptomatic to symptomatic state (clinical symptoms like fever, cough and breathlessness) and changes in the immunity markers [Interleukins (IL) 6, IL10, IL2, Interferon gamma (IFNγ) and Tumor Necrosis Factor (TNF) alpha]. Clinical assessment of COVID-19 as per standard Siddha system of medicine principles and the occurrence of adverse effects will be documented as secondary outcomes. RANDOMISATION: The assignment to the study or control group will be allocated in equal numbers through randomization using random number generation in Microsoft Excel by a statistician who is not involved in the trial. The allocation scheme will be made by an independent statistician using a sealed envelope. The participants will be allocated immediately after the eligibility assessment and informed consent procedures. BLINDING (MASKING): This study is unblinded. The investigators will be blinded to data analysis, which will be carried out by a statistician who is not involved in the trial. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): Sample size could not be calculated, as there is no prior trial on KSK. This trial will be a pilot trial. Hence, we intend to recruit 60 participants in total using a 1:1 allocation ratio, with 30 participants randomised into each arm. TRIAL STATUS: Protocol version 2.0 dated 16th May 2020. Recruitment is completed. The trial started recruitment on the 25th May 2020. We anticipate study including data analysis will finish on November 2020. We also stated that protocol was submitted before the end of data collection TRIAL REGISTRATION: The study protocol was registered with clinical trial registry of India (CTRI) with CTRI/2020/05/025215 on 16 May 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).

Characteristics of COVID-19 Clinical Trials in India Based on the Registration Data on CTRI (Clinical Trials Registry- India): a cross-sectional analysis

ObjectivesThe 2019 pandemic of coronavirus disease (COVID-19) has prompted several efforts to find safe and effective drugs, but little is understood as to where early efforts were centered. Several clinical trials, both Allopathy and AYUSH medicines have been registered in the Clinical Trial Registry of India (CTRI). We aimed to characterize and extract relevant data registered under CTRI for COVID-19. Materials and MethodsA cross-sectional analysis was performed of clinical trials for the treatment of COVID-19 that were registered in the Clinical Trial Registry of India (CTRI) from 1st March 2020 to 22nd June 2020. Relevant trial records were downloaded, deduplicated, and independently analyzed by three reviewers. Main outcomesTrial intervention, design, sponsorship, phase of the trial, and indicated outcomes. Results233 COVID-19 clinical trials, was registered from India in CTRI. Out of these, 146 were Interventional trials, 84 Observational trials, and three Post-marketing surveillance. Questionnaire and survey-based intervention occupy a significant portion. Randomized control trials are large in number 37.8% than non-randomized. 20% of the trials were recruiting patients, and the Research institution (34%) sponsored more than half of the trials. Global trials are minimal, occupying 3% of total trials and Indian trials were 97%. In most of the trials, the interventional agent is either multiple drug combinations or compound drug formulations compared to single drug administration. Among the trials, 46 Allopathic interventions, 41 Ayurveda interventions, 14 Homeopathy interventions, one in Unani, and 2 in yoga and Naturopathy. ConclusionThis study will provide a background of COVID-19 clinical trials registered in CTRI and provide specific issues observed related to clinical trial designs, which offer information to perform clinical trials on COVID-19

List of medicinal plants from Epigraphia Indica.

It is of interest to list plants and its usage in olden days. The history of plants is closely related with the history of medicine since time immemorial. Various literature data shows the usage of medicinal plants. It is linked to various system of medicine like Siddha, Ayurveda and Unani. This is in practice for more than 5000 years. People in olden age had a detailed knowledge on these plants. Hence, we collected such data from the first five volumes of Epigraphia Indica, which was published, by the Archeological survey of India from 1882 to 1977. These data provides a framework on various plants and its usage in various ways, in different time period in human history. This helps us to drive valuable bio-medical information for application in modern scientific biomedical methods. We further plan to sort and glean such data so as to help in evaluating the total biomedical data in Epigraphia Indica to extract useful biological knowledge for application in evidence-based biomedicine.

Assessing the awareness on occupational safety and health hazards among nursing staff of a teaching hospital.

INTRODUCTION: Occupational safety and health hazards in healthcare facilities play a significant role in the lives of care providers and also contribute toward quality patient care. Healthcare workforce gets exposed to physical, chemical, biological, and psychological hazards while discharging their duties, thus demanding for proper knowledge and awareness to address the same. OBJECTIVES: As nursing staff implement the care process directed by the physicians, the current study conducted at a teaching hospital aimed at assessing their awareness on occupational safety and health hazards. METHODOLOGY: A prospective study was conducted on a pilot basis for a period of 3 months in various nursing areas of the hospital. The questionnaire aimed at assessing the awareness of nursing staff on occupational safety and health hazards (5-point scale) was administered on nursing staff (150/170]. Total scores and percentage of responses were computed and the degree of correlation was observed as 0.4 between the participants age, educational qualifications, and total scores. RESULTS: Participant response rate was 88% (150/170). Awareness on occupational safety and health hazards were shown as 43.4%- accidental falls at workplace, 42.7%- complete awareness on latex allergies, 52.7% on dermatitis and respiratory problems, 42% complete aware on accidental fires, 39.4%- burns, 36.7%- electric shocks, 59.4%- complete awareness on biological infections, 54%- respiratory disorders, 48.7%- skin allergies, awareness on usage of PPE to prevent: 67.4%-respiratory problems, 44%- accidental falls; 77.4%- importance of handwashing, 78% - significance of Hepatitis B vaccination, 71.4% - usage of first aid kits in minor accidents, 60%- reporting incidents, and 58%- documentation system for incident reporting. Sum total of scores revealed that 73.3% of the participants were found to be completely aware about all the components of occupational health and safety mentioned in the questionnaire. 22.6%- aware, 3.3%- moderately aware, and < 1% were slightly aware of the same. CONCLUSIONS: The study had highlighted the areas that require knowledge enhancement on occupational safety and health hazards which helps in adopting the best practices at workplace.