the effect of Guduchi (Tinospora cordifolia) as a prophylactic measure among high risk population (Health Care Workers/Containment Zone Population) exposed to COVID-19

Phase 2/3

Recruiting

• Conditions: 2.Subjects who are froma community where at least 1 confirmed case is already identified.

• Registration Number: CTRI/2020/05/025485
• Lead Sponsor: CCRASNIIMH

Brief Summary

In view of no vaccine /treatment available forCOVID-19 infection as on date, there is a need to investigate the potentialintervention. Although there are lot of Clinical studies are ongoing all overthe world, there is a scope for Traditional systems of Medicine also in thesetypes of pandemic conditions, where masses of population are affected. It isimperative that to cater to such a huge population there should be a researchon Traditional systems of medicine also, as these systems are co-existing withthe lifestyles of the people in that particular geographical region. InClassical textbooks of these traditional medicines such type of outbreaks havebeen explained and their possible treatment. This is a attempt to investigatethe role of Ayurveda intervention in prophylaxis of COVID-19 infection to savethe healthy population from being infected.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-29
• Last Update Posted: 2020-12-10

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• 1.Adult Male or Female subjects above the age of 18 years to 68 years of age 2.Subjects who are froma 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 Care	0 15 30 45 days

Secondary Outcome Measures

Name	Time	Method
a)Assessment of subjects not requiring hospitalization	b)Severity of symptoms of hospitalized patients in wards

Trial Locations

Locations (1)

CCRAS-NIIMH; 🇮🇳 Hyderabad, TELANGANA, India

CCRAS-NIIMH

🇮🇳Hyderabad, TELANGANA, India

DR PVV Prasad

Principal investigator

040-24067388

prasadpeyyala@yahoo.co.in