To observe the effect of Ayurvedic medicine (Ashwagandha and Shunti) for the treatment of COVID-19
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/08/027224
- Lead Sponsor
- Central Council for Research in Ayurvedic Sciences New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
1. Mild to moderate cases registered in the Hospital, with COVID 2019 (Confirmed by Antigen test/ RT-PCR) quarantined at identified hospital set up.
2. Participants who can take medicines orally
3. Patients with either sex, 18 to 75 years age
4. Patients willing to provide signed informed consent
1. Cases of severe vomiting which would make oral administration of medicine difficult.
2. Patients with hyperacidity and gastric ulcer to be excluded.
3. Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as Diabetes, Hypertension, Cardiac disorders, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study
4. Cases of respiratory failure and requiring mechanical ventilation.
5. Patients with COVID 19 in critical condition or ARDS or NIAD 8 â??point ordinal score 2 Hospitalized, on invasive mechanical Ventilation or extra corporeal membrane oxygenation
6. Pregnant or lactating women
7. Any patient with proved sensitivity to the trial drugs may be excluded.
8. Any other condition, which as per the investigator would jeopardize the outcome of the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Clinical cure rate: Time to negative conversion of severe acute respiratory syndrome corona-virus 2.(From the day of randomization)Timepoint: On 7th day and 15th day
- Secondary Outcome Measures
Name Time Method 1. Duration of fever and each of the respiratory symptoms. <br/ ><br>2. Improvement in hematological and laboratory parameters (CBC, LFT, RFT, Lipid profile, FBS, ESR, Hs-CRP, LDH, S. Ferritin, D-dimer, TNF-α, IL-6, Serum IgG for COVID-19, Serum IgM for COVID-19, RT-PCR and HRCT Chest Scan). <br/ ><br>3. No of cases reporting any ADR/AE. <br/ ><br>4. Number of patients referred due to progressing/worsening of disease. <br/ ><br>5. Number of cases that required invasive or non-invasive oxygen therapy during the intervention. <br/ ><br>Timepoint: On 7th day and 15th day