The effect of Ayurvedic intervention (Ayurveda Raksha Kit) as a preventive measure in the Pandemic of COVID-19 - A community based study

Phase 3

• Registration Number: CTRI/2020/08/027316
• Lead Sponsor: Central council for research in Ayurvedic sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

a)Participants residents of the identified SC dominated area/colony/village where at least 1 confirmed case is already identified

b)Above the age of 18 years & above

c)Participants who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study

d)Willing to take study medication

Exclusion Criteria

e)Known cases of Covid-19.

f)Pregnant and Lactating females

g)Known cases of uncontrolled Diabetes and Hypertension

h)Participants having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening

i)Participants having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc.

j)Participants taking Steroid treatment and or any kind of immunosuppressive therapy

k)Participants participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study.

l)Participants having a history of allergy to any medicine that is part of the Ayurvedic intervention.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome measures <br/ ><br>1)Comparative assessment of occurrence of COVID-19 infection in Clinically stable participants in community having at least 1 confirmed case already identified with control arm of Standard Prophylactic Care <br/ ><br> <br/ ><br>Timepoint: baseline, 15th day, 30th day, 45th day

Secondary Outcome Measures

Name	Time	Method
Comparative assessment of severity of COVID-19 infection in participants taking Ayurvrda Raksha Kit and the control arm in following situations: <br/ ><br> <br/ ><br>Global assessment of overall change as per the investigator (Efficacy assessment) by using Immunity Status Questionnaire (ISQ); <br/ ><br>To observe the general well-being of people like appetite, bowel habit, sleep among the study population (assessed on VAS scale); <br/ ><br>Safety assessment by evaluation of occurrence of AE/SAETimepoint: baseline, 15th day, 30th day, 45th day