None listed
Conditions
Interventions
Intervention1: Ashwagandha (Withania Somnifera): 250 mg, Dosage schedule:2 tablets BID x 16 weeks
Control Intervention1: Hydroxychloroquine: 400 mg BID (twice a day) with meals on Day 1
subsequently, 400 mg once a week with meal for 16 weeks
Sponsors
Ministry Of AYUSH CCRAS
Eligibility
Inclusion criteria
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 naïve participants V. Willing to come for regular follow up visits VI. Written Informed Consent
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants developing confirmed COVID-19 any time during the duration of the study.Timepoint: week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| (i) AllCOVID-19 cases irrespective of lab confirmation (ii) incidence of respiratory illness(including non-COVID illness such as influenza) (iii) drug related adverse event (iv) improved general health measures of energy and vitality as per Ayurveda assessment (v) improvement on Quality of Life instrument (vi) prevalence of specific IgG antibodies to SARS-CoV-2 and other markers of immune health and oxidative damage Timepoint: Week 16 | — |
Countries
India
Contacts
Public ContactDr Arvind Chopra
Center for Rheumatic Diseases
Outcome results
None listed