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

Phase 3

Not yet recruiting

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2020/11/029444
• Lead Sponsor: Shri Vishwavati Ayurved Chikitsalaya and Research Centre

Brief Summary

This is an open label, randomized, parallelgroup, active controlled, clinical study. The study will be conducted at Symbiosis Medical College forWomen, and Symbiosis University Hospital & Research, Lavale, Pune. having qualified Investigators. The studywill be initiated only after the receipt of ethics committee (EC)approval.  After obtaining the informedconsent, subjects will be screened by undergoing various assessments asmentioned in Schedule of Assessment (Appendix 2) and after confirmingeligibility, eligible subjects will be randomized in the study and assignedeither to the test group receiving a treatment regime of Standard treatment forCOVID - 19 + Madhav Rasayan tablet, for 10 daystreatment period and will be given randomization number. Subjects may or maynot be hospitalized depending upon the severity and clinical condition duringthe treatment period.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-12
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

• Gender: Either male or non-pregnant, non-lactating female aged > 18-60 < years (both inclusive).
• 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

• 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 subject’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, sponsor’s representatives and their first-degree relatives.
• 12 Pregnant and or lactating subjects.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time (Days) to clinical improvement from study enrolment	Baseline, Day of Discharge

Secondary Outcome Measures

Name	Time	Method
Rate of subjects showing improvement	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)	Day 0, Day 5 and / or Day 10 (If Positive on Day 5)
Clinical status as assessed by the 7-point ordinal scale	Time Frame: Day 0, Day 5 and / or Day 10 (If Positive on Day 5)
Proportion of participants in each group with normalization of fever	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 24h	Time Frame: Day 0, Day 5 and / or Day 10 (If Positive on Day 5)
Time to negative SARS-CoV-2 PCR in NP swab	Day 5 or day 10
Duration of oxygen therapy	Day of Discharge
Proportion of participants in each group with need for mechanical ventilation	Day of Discharge
Duration of hospitalization	Day of Discharge
Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs)	Day 0, Day 5 and / or Day 10 (If Positive on Day 5)

Trial Locations

Locations (1)

Symbiosis Medical College for Women and Symbiosis Univeristy Hospital and Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

Symbiosis Medical College for Women and Symbiosis Univeristy Hospital and Research Centre

🇮🇳Pune, MAHARASHTRA, India

Dr Pankaj Bansode

Principal investigator

9822998855

pankaj.bansode@smcw.siu.edu.in