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

A prospective non-randomized open labeled controlled interventional study on the effect of Guduchi (Tinospora cordifolia) as a prophylactic measure among high risk population (Health Care Workers/Containment Zone Population) exposed to COVID-19 - GPC

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025485
Enrollment
5000
Registered
2020-05-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: GUDUCHI CAPSULE: GUDUCHI CAPSULE-250 mg X 2 capsules b.d, for one month Control Intervention1: Standard Prophylactic Care: Standard Prophylactic Care recommended by Government of Telang

Sponsors

CCRASNIIMH
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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: 0 15 30 45 days

Secondary

MeasureTime frame
a) Assessment of subjects not requiring hospitalization b) Severity of symptoms of hospitalized patients in wards c) Patients requiring ICU admission / Ventilator support 3. Safety assessment by evaluation of occurrence of AE/SAE due to consumption of Ayurveda InterventionTimepoint: 0 15 30 45 days

Countries

India

Contacts

Public ContactDr P V V Prasad

NIIMH-CCRAS, Ministry of AYUSH

prasadpeyyala@yahoo.co.in040-24067388

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026