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CTRI Number  CTRI/2020/11/029444 [Registered on: 27/11/2020] Trial Registered Prospectively
Last Modified On: 24/11/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study effect of Madhav Rasayan tablets in COVID 19 patients 
Scientific Title of Study   An open label, randomized, parallel group, controlled, interventional clinical study to evaluate the efficacy and safety of “Madhav Rasayan” tablet as an adjuvant to Standard treatment in mild to moderate COVID-19 subjects 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SVACRC/20/1 V 2.0 Dated 09-Oct-2020  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pankaj H Bansode 
Designation  Principal Investigator 
Affiliation  Symbiosis Medical College for Women and Symbiosis Univeristy Hospital and Research Centre 
Address  Dept of General Surgery Symbiosis Medical College for Women and Symbiosis Univeristy Hospital and Research Centre
Lavale Pune India
Pune
MAHARASHTRA
411042
India 
Phone  411042  
Fax    
Email  pankaj.bansode@smcw.siu.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Shailesh Balkrishna Malekar 
Designation  Head - R & D 
Affiliation  Shree Vishwavati Ayurvedic Chikitsalaya & Research Centre 
Address  Shri Vishwavati Ayurved Chikitsalaya and Research Centre run by Shri Vishwanath Maharaj Rukadikar Trust
Vishwavati 697 B Shri Sadguru Rukadikar Maharaj Marg
Kolhapur
MAHARASHTRA
416001
India 
Phone  9867689658  
Fax    
Email  research@shreevishwavati.com  
 
Details of Contact Person
Public Query  
Name  Dr Tushar Saundankar 
Designation  Trustee 
Affiliation  Shree Vishwavati Ayurvedic Chikitsalaya & Research Centre 
Address  Shri Vishwavati Ayurved Chikitsalaya and Research Centre run by Shri Vishwanath Maharaj Rukadikar Trust
Vishwavati 697 B Shri Sadguru Rukadikar Maharaj Marg
Kolhapur
MAHARASHTRA
416001
India 
Phone  9422331129  
Fax    
Email  drtushars@hotmail.com  
 
Source of Monetary or Material Support  
Shri Vishwavati Ayurved Chikitsalaya and Research Centre run by Shri Vishwanath Maharaj Rukadikar Trust Vishwavati 697/B Shri Sadguru Rukadikar Maharaj Marg Kolhapur 
 
Primary Sponsor  
Name  Shri Vishwavati Ayurved Chikitsalaya and Research Centre 
Address  Shri Vishwavati Ayurved Chikitsalaya and Research Centre run by Shri Vishwanath Maharaj Rukadikar Trust Vishwavati 697/B Shri Sadguru Rukadikar Maharaj Marg Kolhapur 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pankaj Bansode  Symbiosis Medical College for Women and Symbiosis Univeristy Hospital and Research Centre  Depart of Gen Surgery, Ground Floor, Symbiosis Medical College for Women and Symbiosis Univeristy Hospital and Research Centre, Lavale, Pune, India
Pune
MAHARASHTRA 		 9822998855

pankaj.bansode@smcw.siu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Ethics Committee Symbiosis International (Deemed University)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 
Comparator Agent  Standard treatment for COVID – 19 as per hospital protocol  Standard treatment for COVID – 19 as per hospital protocol 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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 ≥ 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 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Time (Days) to clinical improvement from study enrolment   Baseline, Day of Discharge 
 
Secondary Outcome  
Outcome  TimePoints 
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) 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   03/12/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is an open label, randomized, parallel group, active controlled, clinical study. The study will be conducted at Symbiosis Medical College for Women, and Symbiosis University Hospital & Research, Lavale, Pune. having qualified Investigators. The study will be initiated only after the receipt of ethics committee (EC) approval.  After obtaining the informed consent, subjects will be screened by undergoing various assessments as mentioned in Schedule of Assessment (Appendix 2) and after confirming eligibility, eligible subjects will be randomized in the study and assigned either to the test group receiving a treatment regime of Standard treatment for COVID - 19 + Madhav Rasayan tablet, for 10 days treatment period and will be given randomization number. Subjects may or may not be hospitalized depending upon the severity and clinical condition during the treatment period.

 
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