Clinical study to evaluate the effect of Ayurveda intervention as a prophylaxis for COVID-19 in Healthcare workers
Phase 3
Completed
- Registration Number
- CTRI/2020/10/028424
- Lead Sponsor
- Ministry Of AYUSH Government of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Consenting Healthcare Workers at Aster CMI Hospital
2.HCWs with Active Asthma/ Bronchitis/ COPD but not on any internal medication.
3.Willingness/Consent to participate in the Trial
4.18 years and older
Exclusion Criteria
1.Active COVID-19 disease
2.Prior COVID-19 disease
3.Pregnant Women and Breast feeding Mother
4.Children Below 1 year
5.HIV
6.Organ Donors
7.Patients with Organ Transplant
8.Participation in any other COVID-19/COPD Trial
9.Patients with Active Malignancy
10.Patients with Chronic Kidney with GFR <30
11.Patients with Bleeding Disorders
12.Patients with Active Upper or Lower Respiratory Tract Infection Disorders on any Allopathy Internal Medication
13.Health care workers who are on HCQ medication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method % Of staff members who develop NCMP Stages, by stage, within 1month/2months/3months of enrolment into study. <br/ ><br>COVID-19-free survivalTimepoint: 3 months
- Secondary Outcome Measures
Name Time Method Incidence of confirmed SARS-CoV-2 detection, Incidence of possible COVID-19 symptoms , WHO Ordinal Scale, Risk Rating at Start, 3 months , or Withdrawal, Incidence of Hospitalization for COVID-19 or death , QoL(Quality of Life), Stress Scale, Ayurveda Swasthya Lakshanas, Biomarkers(at start and end of study;Blood Immune Cell Count(leukocyte, neutral, lymphocyte counts and absolute lymphocyte) <br/ ><br>Serum Inflammatory Markers(c-reactive protein) <br/ ><br>ESR, Platelet, Serum Creatinine <br/ ><br>Timepoint: 3 months