Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Capsule containing standardized extract of Aswagandha, Amla & Shilajeet: 125 mg, single daily for 12 weeks
125 mg, twice daily for 12 weeks
250 mg, twice daily for 2 weeks
Control Int
Sponsors
NATREON INC
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. To evaluate the underlying mechanism of action of the test product on acquired immunity. 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. Intensity and duration of solicited and unsolicited systemic serious adverse events (AEs/SAEs/ADR) related to trial drug during the treatment course. Timepoint: 18 months | — |
Countries
India
Contacts
Public ContactDr Srikanta Pandit
Department of Kayachikitsha J.B. Roy State Ayurvedic Medical College and Hospital
Outcome results
None listed