Clinical study on Zandu Chyavanprash as a preventive remedy in pandemic of Covid-19.

Phase 2

Completed

Registration Number: CTRI/2021/01/030454

Lead Sponsor: Emami Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Healthy individuals will be considered as those who do not have any acute medical condition or chronic medical or surgical condition that requires either immediate or continuous medical monitoring or treatment.

2. Subjects tested Negative for total antibodies for COVID-19

3. 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

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. Known cases of Diabetes

4. 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. Subjects having a past history of allergy to Chyawanprash like products

8. 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in incidence of COVID-19 [by RT- PCR and or total antibody fo r[COVID-19] in subjects taking Zandu Chyavanprash and those not taking it <br/ ><br>2. Change in incidence of other non COVID-19 infections in subjects taking Zandu Chyavanprash and those not taking itTimepoint: Screening visit (day -5), baseline visit (day 0), day 15, day 30, day 45, day 60, day 75 and day 90.

Secondary Outcome Measures

Name	Time	Method
1. Change in severity of COVID-19 (when it occurs) between two groups <br/ ><br>2. Change in number of subjects requiring hospitalization etc between two groups. <br/ ><br>3. Change in ordinal scale for clinical improvement of COVID-19 between two groups <br/ ><br>4. Change in incidence and severity of other allergy related health between two groups <br/ ><br>5. Changes in Quality of life between two groups <br/ ><br>6. Change in global assessment for overall change as per the investigator <br/ ><br>7. AE and SAE assessmentTimepoint: Screening visit (day -5), baseline visit (day 0), day 15, day 30, day 45, day 60, day 75 and day 90.