CTRI/2020/08/027224
Completed
Phase 2
A Prospective Randomized Controlled Clinical Trial to evaluate the Efficacy and Safety of Ayurveda Interventions (Ashwagandha Tablet and Shunti Capsule) in the management of COVID-19 infection (Mild to Moderate symptoms)
Central Council for Research in Ayurvedic Sciences New Delhi0 sites48 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Sponsor
- Central Council for Research in Ayurvedic Sciences New Delhi
- Enrollment
- 48
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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