Clinical study on Guduchi Ghana Vati as a preventive remedy in pandemic of COVID-19

An Open label, Multi centric, Randomized, Comparative, Prospective, Interventional Community based Clinical Study to Evaluate Safety and Efficacy of Guduchi Ghana Vati as a Preventive Remedy on Healthy Individuals in Pandemic of COVID-19 - GGVC19

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/05/025488

Enrollment

12000

Registered

2020-05-31

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 Ghana Vati: Each Guduchi Ghana Vati contains Guduchi Ghana (Tinospora cordifolia) 500 mg with preservatives and excipients Dosage and Treatment Duration: 2 tablets twice daily

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy, Male or Female subjects between the age group of 18 years to 70 years (both inclusive). Healthy individuals will be considered as those who do not have any acute medical condition or chronic medical/surgical condition that requires either immediate or continuous medical monitoring or treatment. 2. Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study.

Exclusion criteria

Exclusion criteria: 1. Pregnant and Lactating females 2. Subjects who have been confirmed of having COVID-19 and have been isolated for its treatment. Subjects having recently suffered and recovered of COVID-19 will also be excluded from the study 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 and 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 3 months prior to screening in the present study. 7. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol

Design outcomes

Primary

Measure	Time frame
Comparative assessment of incidence of COVID-19 in subjects taking GUDUCHI GHANA VATI and those not taking it over a period of 45 daysTimepoint: (day-5, day 0, day-15, day-30, day-45)	—

Secondary

Measure	Time frame
1. Comparative assessment of incidence of other non COVID-19 infections in both the groups 2. Comparative assessment of severity of COVID-19 in both the groups. 3. Comparative assessment of number of subjects requiring hospitalization, number of days of hospitalization, ICU admission, Ventilator support and mortality rate. 4. Global assessment of overall change as per the investigator 5. Safety assessment by evaluation of occurrence of AE/SAE Timepoint: (day-5, day 0, day-15, day-30, day-45)	—

Measure

Time frame

1. Comparative assessment of incidence of other non COVID-19 infections in both the groups 2. Comparative assessment of severity of COVID-19 in both the groups. 3. Comparative assessment of number of subjects requiring hospitalization, number of days of hospitalization, ICU admission, Ventilator support and mortality rate. 4. Global assessment of overall change as per the investigator 5. Safety assessment by evaluation of occurrence of AE/SAE Timepoint: (day-5, day 0, day-15, day-30, day-45)

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Countries

India

Contacts

Public ContactDr PawanKumar Godatwar

National Institute of Ayurveda, Jaipur

gpawankumar@rediffmail.com9314502834

Outcome results