A clinical trial to study the effect of herbal medicine on enhancing immune function in COVID recovery patients

INTERVENTION: 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 Intervention1: Placebo (Vitamin Capsule): Vitamin capsule twice daily for 12 weeks CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: 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: 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 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