Study of ASHWAGANDHA TABLET on healthy individuals to prevent covid 19

Observational Study of ASHWAGANDHA TABLET intake as a preventive measure in pandemic of COVID-19 â?? An open label, Randomized, Controlled, Prospective, Interventional, Community-based Clinical study on healthy subjects

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/05/025166

Enrollment

1200

Registered

2020-05-14

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: Ashwagandha tablet: Ashwagandha tablet (250mg ) two tablet twice daily for one month Control Intervention1: nil: nil

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adult Male or Female subjects above the age of 18 years to 68 years. 2.Subjects who are from 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

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

Measure	Time frame
Primary outcome parameter: 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 Timepoint: 15th day , 30th day and 45th day	—

Secondary

Measure	Time frame
1. Comparative assessment of severity of Covid-19 infection in subjects taking ASHWAGANDHA Tablet and those not taking it in following situations: a) Assessment of subjects not requiring hospitalization b) Severity of symptoms of hospitalized patients in wards c) Patients requiring ICU admission / Ventilator support 2. Global assessment of overall change as per the investigator (Efficacy assessment) Timepoint: 15th day, 30th day and 45 th day	—

Measure

Time frame

1. Comparative assessment of severity of Covid-19 infection in subjects taking ASHWAGANDHA Tablet and those not taking it in following situations: a) Assessment of subjects not requiring hospitalization b) Severity of symptoms of hospitalized patients in wards c) Patients requiring ICU admission / Ventilator support 2. Global assessment of overall change as per the investigator (Efficacy assessment) Timepoint: 15th day, 30th day and 45 th day

—

Countries

India

Contacts

Public ContactDr C Muralikrishna

Regional Ayurveda Research Institute Vijayawada

mkchagamreddy@gmail.com9492030564

Outcome results