Guduchi Ghanavati as a prophylactic measure among population at high risk to SARS-CoV-2 exposure
- Conditions
- Population at high risk for SARS CoV 2 infection
- Registration Number
- CTRI/2020/06/025525
- Lead Sponsor
- Institute for Post Graduate Teaching and Research in Ayurveda
- Brief Summary
Currently, there is no availability of vaccine againstCOVID-19 and no drug with proven clinical efficacy. There areseveral options that might be effective in prevention or treatment. *Guduchi (Tinospora cordifolia*(Willd.) Miers*)* is one such important *Rasayana* drug in Ayurvedic pharmacopeiahaving wide therapeutic attributes.Itis recommended as *Rasayana, Balya* (strength)*, Jwaraghna* (antipyretic) in Ayurvedic classics and used for its anti-inflammatory,immunomodulatory,anti-allergic,antipyretic properties etc. Clinical efficacy of *Guduchi*is also evaluated through many clinical studies in different conditions. *Guduchi Ghana* (concentrated form of *Guduchi*decoction) is the secondary *Kalpana* (dosage form) derived from theprimary *dosage form*, i.e. *Kwatha* (decoction).It is evaluated for its anti-inflammatory, immunomodulatory, anti-microbial,hypoglycemic and anti-hyperglycemic actions in experimental studies. To address these challenges and accelerate theresearch needed in resource-limited settings, this study is planned to evaluateeffect of prophylactic Guduchi Ghana to COVID-19 infection and health status inadult volunteers who are at high risk of exposure.
This study is designed as Open label,non-randomized, interventional, controlled (no treatment group) trial. Method of Sampling is Non probability sampling (conveniencesampling method). Thetotal sample size of the study will be 20,000 subjects. These subjects will be divided into 2groups of 15,000subjects in trial drug group and 5,000 subjects in control group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 20000
Subjects at high risk of exposure to COVID 19 infection such as Health care workers involved in treatment of COVID19 cases Frontline workers of city where COVID 19 cases detected Family members of COVID19 cases or direct contact People in quarantine People in containment zones Subjects who are ready to provide written or digital informed consent and who are willing to participate.
Pregnant and Lactating female COVID 19 positive cases Known cases of uncontrolled Diabetes and Hypertension or any other systemic uncontrolled conditions Having immune compromised status like HIV Hepatitis Tuberculosis Cancer etc Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening Subjects taking Steroid treatment and or any kind of immunosuppressive therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence rate of COVID 19 infection 0 14 28 days
- Secondary Outcome Measures
Name Time Method Changes in Immune Status Questionnaire 0 14 and 28 days Changes in WHO QOL BREF 0 14 and 28 days
Trial Locations
- Locations (5)
Akhandanand Ayurveda college
🇮🇳Ahmadabad, GUJARAT, India
Government Ayurveda College Vadodara
🇮🇳Vadodara, GUJARAT, India
IPGTRA
🇮🇳Jamnagar, GUJARAT, India
Sheth J P Government Ayurved College
🇮🇳Bhavnagar, GUJARAT, India
State Model Government Ayurved College
🇮🇳Gandhinagar, GUJARAT, India
Akhandanand Ayurveda college🇮🇳Ahmadabad, GUJARAT, IndiaHarshit ShahPrincipal investigator9824068760akhandanandprincipal@gmail.com