Randomized double-blind placebo controlled parallel-group phase 1-2 proof-of-concept clinical trial of the herbal preparation Sri Weera Badhra Dhamma Prathishakthi Jeewa Panaya© for patients with asymptomatic or with mild to moderate COVID-19.
- Conditions
- COVID-19, SARS-COV-2 infection
- Registration Number
- SLCTR/2021/001
- Lead Sponsor
- Ministry of Production, Supply and Regulation of Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
1. All consenting male and female adults (18–80 years of age)
2. Asymptomatic or mild or moderate disease (as defined in the case definition)
3. Two positive RT-qPCR tests
4. Negative antibody test
5. Cycle threshold (Ct) value <38 at the time of recruitment
Case definition: US Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research, Centre for Biologics Evaluation and Research. COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry. 2020;(May):1–11.
1. Pregnant (known pregnancy or positive urine strip test) and lactating females
2. Patients who have ingested Sri Weera Badhra Dhamma Prathishakthi Jeewa Panaya© within the past six weeks
3. Patients with known allergy to the individual ingredients (Bees honey, nutmeg, fennel, raw ginger) of Sri Weera Badhra Dhamma Prathishakthi Jeewa Panaya©
4. Any diagnosed co-morbidity such as diabetes, hypertension, renal disease, liver disease or bronchial asthma.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method