A clinical trial to study the effect of herbal medicine on enhancing immune function in COVID recovery patients
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/12/029476
- Lead Sponsor
- ATREON INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Age 18-60 years
Presently SARS-CoV-2 RT-PCR test negative
Who have recovered from SARS-CoV-2
Mild to moderate SARS-CoV-2 infection in the past
Having a hospital discharge report of SARS-CoV-2
Residence within the catchment area of the hospital
Provision of signed informed consent
Age below 18 years and above 60 years
Signs& symptoms of SARS COV-2
Past history of serious cardiac problem
Past history of severe diabetes
Past history of serious renal failure
Past history of serious respiratory diseases
Past history of serious liver disorders
Past history of serious mental disorders
Presently pregnant or lactating women or expecting to become pregnant during the study period
Unwilling to give written consent
Use of any medications or supplements which, in the opinion of the investigators, may influence the results of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The role of purified standardized extract of Aswagandha, Amla & Shilajeet on body immune functions of post SARS-CoV-2 recovered patients (not more than 6 months) as measured by means of molecular immune markers like, CRP, IgG, IgM, CD4+, CD8+, IL1b, IL6, IL10, TNFα, Interferon γ suspected to viral infections during COVID-19Timepoint: 18 months
- Secondary Outcome Measures
Name Time Method Compare the immunogenicity before and after treatment with the test product at different doses on post SARS-CoV-2 recovery patients as well as with placebo (Vitamin) treated control groups. <br/ ><br>To evaluate the underlying mechanism of action of the test product on acquired immunity. <br/ ><br>Timepoint: 18 months;To evaluate the safety of the test product in post SARS-CoV-2 recovered patients by examination of their physical health, complete blood haemogram, lipid profile, liver function, renal function, chest radiogram, electrocardiogram, echocardiogram etc. <br/ ><br>Intensity and duration of solicited and unsolicited systemic serious adverse events (AEs/SAEs/ADR) related to trial drug during the treatment course. <br/ ><br>Timepoint: 18 months