Prophylactic study of Ashwagandha and HCQ in health care providers

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2021
INTERVENTION: 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 Intervention1: Hydroxychloroquine: HCQ is considered to be anti viral and anti inflammatory. 400 mg tablet. 400 mg tablet twice a day on Day 1, 400 mg once a week for 7 weeks CONDITION: PRIMARY OUTCOME: (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 OUTCOME: 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 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
Epistemonikos ID: 12ecba7b5885c6ee31b9ec02e77ce24bdb7dcb5a
First added on: Aug 05, 2021