Ashwagandha in the prevention of COVID-19 in Health Care workers

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

I.Participants of either sex, 20-65 years of age

II.Participants testing negative for SARS-CoV-2 by RT PCR technique using nose and throat swab

III.Participants testing negative for anti-SARS-CoV-2 IgG antibodies

IV.HCQS naÃ¯ve participants

V.Willing to come for regular follow up visits

VI.Written Informed Consent

Exclusion Criteria

I.Participants with hypersensitivity or intolerance and contraindications(psoriasis, porphyria and Glucose-6-Phosphate Dehydrogenase deficiency) to study drug use

II.Pregnant women, lactating women and women of child bearing potential not willing to follow adequate contraception

III.History of having received any investigational drug in the preceding one month

IV.History of regular intake of Ayurvedic or any other form of CAM (Complementary Alternative Medicine) formulation in the preceding 1 month

V.Chronic, Severe, Unstable, Uncontrolled medical disease such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders, Retinopathy or other disease of concern which may put the participant at increased risk during the study

VI.Prolonged concurrent intake of any drug that is known to prolong QT interval on the ECG as per physician discretion and these drugs include anti-arrhythmic drugs, quinidine, chlorpromazine, haloperidol, olanzapine, thioridazine, fluoxetine, antibiotics belonging to quinolone and macrolide family, antibiotics, fenfluramine and other appetite suppressants, Beta-2 agonists, terfenadine and other anti- hitaminic drugs, liquorice and potassium lowering drugs

VII.Serum Liver Enzymes >1.5 times of upper normal limits, Serum creatinine >2 mg/dL, Blood Urea >70 mg/dL, Blood Hemoglobin <9 gm/dL

VIII.Non co-operative attitude of the patient

IX.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
Proportion of participants developing confirmed COVID-19 any time during the duration of the study.Timepoint: week 16

Secondary Outcome Measures

Name	Time	Method
(i)AllCOVID-19 cases irrespective of lab confirmation <br/ ><br>(ii)incidence of respiratory illness(including non-COVID illness such as influenza) <br/ ><br>(iii)drug related adverse event <br/ ><br>(iv)improved general health measures of energy and vitality as per Ayurveda assessment <br/ ><br>(v)improvement on Quality of Life instrument <br/ ><br>(vi)prevalence of specific IgG antibodies to SARS-CoV-2 and other markers of immune health and oxidative damage <br/ ><br>Timepoint: Week 16