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
CSIR Ministry of Ayush
Eligibility
Inclusion criteria
Inclusion criteria: 1)Participants of either sex,20 to 69 years of age 2)Participants tested negative COVID-19 by nose throat swab using PCR technique 3)Participants should be naive for HCQ 4)Willing to come for regular follow-up visits 5)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Individuals with known hypersensitivity or Intolerance and contraindications (psoriasis, porphyria and Glucose-6-Phosphate Dehydrogenase deficiency) 2)Pregnant women, lactating women and women of child bearing potential. hypersensitivity orIntolerance to Hydroxychloroquine will not be assigned to HCQ intervention arms in Group A and Group B Contraindications to HCQ use such as psoriasis, porphyria, and Glucose-6-phosphate dehydrogenase (G6PD) deficiency 3)Individuals 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-hitaminic drugs, liquorice and potassium lowering drugs 7)History of taking any kind of Ayurvedic formulation or any other form of CAM (Complimentary 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.
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 periodTimepoint: 1)Baseline 2)4 Week 3)8 Week 4)12 Week | — |
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 ContactAnand More
All India Institute of Ayurveda
Outcome results
None listed