A clinical trial to study effect of Madhav Rasayan tablets in COVID 19 patients

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2020
INTERVENTION: 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 day for next 5 days + Standard treatment for COVID ‐ 19 as per hospital protocol Control Intervention1: Standard treatment for COVID â?? 19 as per hospital protocol: Standard treatment for COVID â?? 19 as per hospital protocol CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: Time (Days) to clinical improvement from study enrolmentTimepoint: Baseline, Day of Discharge SECONDARY OUTCOME: 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 INCLUSION CRITERIA: 1. Gender: Either male or non‐pregnant, non‐lactating female aged > 18‐60 < years (both inclusive). 2. Subjects with RT‐PCR confirmed diagnosis of COVID‐19 3. Subjects with mild to moderate COVID‐19 infection having Respiratory rate â?¥ 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
Epistemonikos ID: a95f041a560b5b8419d2aa7152fb2a7198f8499f
First added on: Dec 05, 2020