Effect of chyawanprash on immune system when administered after covid-19 vaccination in health care personnel

Not Applicable

Not yet recruiting

• Registration Number: CTRI/2021/10/037479
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.All healthcare professionals and staff of age group between 25 to 60 years, after 14 days of 2nd dose of COVID-19 vaccine (COVISHIELD), negative for SARS- Cov-2 at screening, (tested by rt-PCR), at DMIMS, without co-morbid condition or stable with ongoing medications, with exposure/chance of exposure to COVID 19 positive cases.

2.Who is willing to provide signed informed consent

High-Risk Group- It includes doctors, nursing staff, and other paramedical staff like attendants who are directly looking after and examining COVID patients.

Low risk- other faculty members & hospital staff who are present in the institute but not visiting the corona ward.

Exclusion Criteria

1.Not vaccinated with COVID-19 vaccine (1st and 2nd dose).

2. Pregnant and lactating females.

3.Immune compromised cases.

4.Laboratory confirmed COVID-19 with or without symptoms

5. Known allergy to any of the medications used in this trial.

6. Not willing to participate in the study.

7. History of receiving any investigational drug in the preceding one month.

8.Subjects who are taking any other medicine as prophylaxis such as HCQ or any other CAM (Complimentary Alternative Medicine) formulation in the preceding 1 month.

9.Any condition or circumstances which in the opinion of the investigator may make a participant unlikely or unable to complete the study or comply with study procedures and requirements

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of participants with SARS- Cov-2 positivity as estimated by RT-PCR of nasopharyngeal swab or by Chemiluminiscenceassay during the study duration.Timepoint: 6 months

Secondary Outcome Measures

Name	Time	Method
The number of participants who developed any infective diseases during the trial period and percentage of participants with Upper respiratory tract illness. <br/ ><br>2.The proportion of all incident cases with drug-related adverse events. <br/ ><br>3.The proportion of cases and absolute change in improvement in general and mental health and other QOL issues described in the questionnaires: SF-36 and Patient Health Questionnaire <br/ ><br>4.The safety profile of the intervention. <br/ ><br>5.Immune and inflammatory markers <br/ ><br>Timepoint: 6 months