Ashwagandha for prevention against SARS-CoV-2 Infection: A Randomized Hydroxychloroquine Controlled drug trial in high risk Health Care Providers

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Participants of either sex, 20 to 69 years of age

2.Participants tested negative for COVID-19 by nose and throat swab using RT PCR technique

3.HCQ naÃ¯ve participants

4.Willing to come for regular follow â?? up visits

5.Written Informed Consent

Exclusion Criteria

1.Participants with hypersensitivity or Intolerance and contraindications (psoriasis, porphyria and Glucose-6-Phosphate Dehydrogenase deficiency)

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

3.Participants with known allergy or contraindication to Ashwagandha

4Have any Chronic,Severe,Unstable,Uncontrolled medical disease such as Diabetes Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the participant at increased risk during the study

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

6.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- histaminic drugs, liquorice and potassium loweringdrugs

7.History of taking any kind of Ayurvedic formulation or any other form of CAM (Complementary Alternative Medicine) therapy in the preceding 2 months

8.Unwilling to come for regular follow-up for the entire duration of the study.

9.Non â?? co-operative attitude of the participant

10.Any condition that, in the opinion of the investigator, does not justify the participantâ??s inclusion in the study.

Liver enzymes > 1.5 times of upper normal limits, Serum creatinine > 2 mg/dL, Blood urea > 70 mg/dL

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(i)Proportion of SARS-CoV-2 infection free participants on completion of study <br/ ><br>(ii)Proportion of participants contracting COVID-19 during the study period <br/ ><br>Timepoint: WEEK 12

Secondary Outcome Measures

Name	Time	Method
proportion of participants developing COVID-19, drug related adverse event, drug tolerability, General Health Related Questionnaire (behavior, habit and fitness/ HR-BHF), Quality of life (WHO QOL Brief), Ayurveda measures, Immune Status (serology for specific anti SARS-CoV-2 IgM and IgG antibodies)Timepoint: week 12