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Research study to evaluate the impact of Selected Ayurvedic interventions in containment zone

A prospective non-randomized open label controlled interventional study on the effect of Guduchi Ghan Vati/ Sudarshan Ghan Vati as a prophylactic measure among Containment Zone population exposed to COVID 19"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025385
Enrollment
30000
Registered
2020-05-27
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 Ghan Vati/Samshamani Vati: 1 gm per person/day, 500 mg two times (BID) for 30 days. Route would be oral Control Intervention1: Hand sanitizer Face Mask Social Distancing: To be

Sponsors

Central Council for Research in Ayurvedic Sciences
Lead Sponsor
Ministry of AYUSH
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants who are from a community where at least 1 confirmed case is already identified. 2. 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

Exclusion criteria

Exclusion criteria: • Known cases Covid-19. • Pregnant and Lactating females • Known cases of uncontrolled Diabetes and Hypertension • Participants having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening • Participants having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc. • Participants taking Steroid treatment and or any kind of immunosuppressive therapy • Participants participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. • Participants having a 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

Design outcomes

Primary

MeasureTime frame
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 CareTimepoint: 0, two weeks, 4 weeks, 6 weeks.

Secondary

MeasureTime frame
Comparative assessment of severity of COVID-19 infection in participants taking Guduchi Ghan Vati/ Sudarshan Ghan Vati and the control arm in following situations: 1. Assessment of participants not requiring hospitalization 2. Severity of symptoms of hospitalized patients in wards 3. Patients requiring ICU admission / Ventilator support 4. Global assessment of overall change as per the investigator (Efficacy assessment) Timepoint: Total 45 days (0, 2, 4, 6 weeks)

Countries

India

Contacts

Public ContactVipin Sharma

CCRAS

sharma.vipin@nic.in9899437195

Outcome results

None listed

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