Study of effect of Yashtimadhu tablet for the prevention of COVID -19 on healthy individuals.

Phase 2

Registration Number: CTRI/2020/05/025093

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

Inclusion Criteria

1.Adult Male or Female subjects above the age of 18 years to 68 years.

2.Subjects who are from a community where at least 1 confirmed case is already identified.

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

Exclusion Criteria

1.Pregnant and Lactating females

2.Known cases of uncontrolled Diabetes and Hypertension.

3.Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening

4.Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc.

5.Subjects taking Steroid treatment and or any kind of immunosuppressive therapy

6.Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study.

7.Subjects having a past history of allergy to any medicine that is part of the Ayurvedic intervention.

8.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.Comparative assessment of occurrence of COVID-19 infection in healthy volunteers in community having at least 1 confirmed case already identified with control arm of Standard Prophylactic CareTimepoint: 15,30 and 45th day

Secondary Outcome Measures

Name	Time	Method
1.Comparative assessment of severity of Covid-19 infection in subjects taking YASHTIMADHU TABLET and those not taking it in following situations: <br/ ><br>a)Assessment of subjects not requiring hospitalization <br/ ><br>b)Severity of symptoms of hospitalized patients in wards <br/ ><br>c)Patients requiring ICU admission / Ventilator support <br/ ><br>2.Global assessment of overall change as per the investigator (Efficacy assessment) <br/ ><br>Timepoint: 15,30 and 45th day