Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Madhav Rasayan tablet with Standard treatment for COVID - 19: Madhav Rasayan, 1 Tablet (250 mg) thrice a day for first 5 days and then onwards 1 tablet Madhav Rasayan (250 mg) once a da
Sponsors
Shri Vishwavati Ayurved Chikitsalaya and Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Gender: Either male or non-pregnant, non-lactating female aged > 18-60 2. Subjects with RT-PCR confirmed diagnosis of COVID-19 3. Subjects with mild to moderate COVID-19 infection having Respiratory rate >= 24/min and SpO2 > 90% on room air 4. Subjects willing to give written informed consent 5. Subjects able to take the drug orally and comply with the study protocol 6. Women of child bearing potential must have a negative urine pregnancy test prior to study entry
Exclusion criteria
Exclusion criteria: 1 Subjects with persistent vomiting 2 Critically ill subjects 3 Patient with Shock 4 Subjects with known active hepatitis, tuberculosis 5 Subjects with altered mental state if on medication 6 Subjects with multiple organ failure requiring ICU monitoring and treatment 7 Subjects with respiratory failure and requiring mechanical ventilation 8 Subjects with any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g. heart failure, hypertension, liver disease, diabetes, anemia etc.) that, in the opinion of investigator precludes the subjectâ??s participation in the study or interferes with the interpretation of the study results. 9 Subjects with known history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus. 10 Patient who have participated in another investigational study within 3 months prior to enrolment in this study 11 Investigators, study personnel, sponsorâ??s representatives and their first-degree relatives. 12 Pregnant and or lactating subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time (Days) to clinical improvement from study enrolmentTimepoint: Baseline, Day of Discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical status as assessed by the 7-point ordinal scaleTimepoint: Time Frame: Day 0, Day 5 and / or Day 10 (If Positive on Day 5);Duration of hospitalizationTimepoint: Day of Discharge;Duration of oxygen therapyTimepoint: Day of Discharge;Proportion of participants in each group with need for mechanical ventilationTimepoint: Day of Discharge;Proportion of participants in each group with normalization of feverTimepoint: Time Frame: Day 0, Day 5 and / or Day 10 (If Positive on Day 5);Proportion of participants in each group with oxygen saturation more than 94% on room air for more than 24hTimepoint: Time Frame: Day 0, Day 5 and / or Day 10 (If Positive on Day 5);Rate of subjects showing improvementTimepoint: Day 0, Day 5 and / or Day 10 (If Positive on Day 5);Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs)Timepoint: Day 0, Day 5 and / or Day 10 (If Positive on Day 5);showing improvement of 2 points in 7 category ordinal scale (with 7 points the worst)Timepoint: Day 0, Day 5 and / or Day 10 (If Positive on Day 5);Time to negative SARS-CoV-2 PCR in NP swabTimepoint: Day 5 or day 10 | — |
Countries
India
Contacts
Public ContactDr Tushar Saundankar
Shree Vishwavati Ayurvedic Chikitsalaya & Research Centre
Outcome results
None listed