An interventional study to access the effect of Ayurvedic medicine in positive cases of COVID-19.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/08/027007
- Lead Sponsor
- Ministry of AYUSH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Individuals of either sex above the age of 15 years to 65 years.
2.Subjects testing positive for SARS CoV-2 by RT-PCR, presenting with no symptoms or mild symptoms (as defined by US-CDC).
3.Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study
1.Cases of COVID-19 with clinical severity ranging from moderate to critical (as defined by US-CDC).
2.Pregnant and Lactating females.
3.Subjects having uncontrolled and unstable co morbidities.
4.Immunocompromised subjects or those taking any kind of immunosuppressive therapy.
5.COVID-19 positive cases participating as subjects in other COVID-19 clinical trials.
6.Subjects having a past history of allergy to any medicine that is part of the Ayurvedic intervention. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)To assess the effectiveness of Ayurvedic fixed drug combination (Mahasudarshan ghana vati, Samsamani vati and Elakanadi kashaya) in preventing the progression of severity of the disease in SARS-CoV 2 tested positive asymptomatic and mild cases of COVID-19.Timepoint: 3 months
- Secondary Outcome Measures
Name Time Method 1)To assess changes in Quality of Life (QoL) of the subjects using WHO QOL-BREF scale. <br/ ><br>2)To assess the safety of Ayurvedic drug combination by observing for adverse events. <br/ ><br>Timepoint: 3 months