None listed
Conditions
Interventions
Intervention1: Ashwagandha (Withania somnifera: Ashwagandha has immunomodulant and immune enhancing activity. It is anti oxidant and promotes health
250 mg, 2 tablets twice a day for 12 weeks
Control
Sponsors
MINISTRY OF AYUSH
COUNCIL OF SCIENTIFIC AND INDUSTRIAL RESEARCH
Eligibility
Inclusion criteria
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 naïve participants 4.Willing to come for regular follow â?? up visits 5.Written Informed Consent
Exclusion criteria
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 4 Have 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (i)Proportion of SARS-CoV-2 infection free participants on completion of study (ii)Proportion of participants contracting COVID-19 during the study period Timepoint: WEEK 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDR ARVIND CHOPRA
CENTER FOR RHEUMATIC DISEASES
Outcome results
None listed