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CTRI Number  CTRI/2020/07/026343 [Registered on: 03/07/2020] Trial Registered Prospectively
Last Modified On: 29/06/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Ayurveda Rasayana therapy ]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Ayurvedic Rasayana treatment as an addon therapy to improve the results in management of coronavirus disease 
Scientific Title of Study   Improving therapeutic outcomes in the treatment of mild to moderate corona virus disease in COVID 19 positive patients via oral administration of Ayurveda formulations a randomized placebo controlled multicentric study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AR/RC/T-01  Protocol Number 
Therapautic Study   NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Avinash Kadam 
Designation  Project Coordinator 
Affiliation  Dept of Clinical Research 
Address  Ayurved Rasayani Nande Balewadi Road Mahalunge Pune

Pune
MAHARASHTRA
411045
India 
Phone  9970259583  
Fax  00  
Email  avinashk@rbpl.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Avinash Kadam 
Designation  Project Coordinator 
Affiliation  Ayurved Rasayani 
Address  Nande Balewadi Road Mahalunge Pune

Pune
MAHARASHTRA
411045
India 
Phone  9970259583  
Fax  00  
Email  avinashk@rbpl.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Avinash Kadam 
Designation  Project Coordinator 
Affiliation  Ayurved Rasayani 
Address  Nande Balewadi Road Mahalunge Pune

Pune
MAHARASHTRA
411045
India 
Phone  9970259583  
Fax  00  
Email  avinashk@rbpl.co.in  
 
Source of Monetary or Material Support  
Ayurved Rasayani . Nande Mahalunge Road Mahalunge. Tal Mulshi Pune-411045 
 
Primary Sponsor  
Name  Ayurved Rasayani  
Address  Mhalunge Nande Road Mhalunge Padale Tal Mulshi Dist Pune 411045 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Mahesh Asalkar  Yashwantrao Chavan Memorial Hospital   Dept of Gyanecology .2nd Floor .PGI YCM Yashwantrao Chavan Memorial Hospital YCM Hospital Rd Sant Tukaram Nagar Pimpri Colony Pune Maharashtra 411018
Pune
MAHARASHTRA 		 9326972948

mahesh@asalkarclinic.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee YCM Hospital Pune   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, (2) ICD-10 Condition: J101||Influenza due to other identifiedinfluenza virus with other respiratory manifestations,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ayurveda therapy consisting of Pranvir Capsule and Capsule Yashada Rasayana   Pranvir capsules : 2 capsules twice daily orally with warm water. Yasada capsules: 1 capsule twice daily orally with warm water 
Comparator Agent  Placebo  Pranvir capsules placebo : 2 capsules twice daily orally with warm water. Yasada capsules placebo: 1 capsule twice daily orally with warm water 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Age 18 to 60 years

2 COVID-19 positive as determined by PCR or other approved commercial or public health assay

3 Willing and able to provide written informed consent prior to performing study procedures 
 
ExclusionCriteria 
Details  1 Participation in any other clinical trial of an experimental treatment for COVID 19

2 Patients with severe COVID 19 disease defined as follows

3 Respiratory distress as determined by ≥30 breaths per min

oxygen saturation at rest ≤85%

Severe disease complications e g respiratory failure requirement of mechanical ventilation, septic shock or non-respiratory organ failure

4 Patients with deranged liver functions i.e Total bilirubin ≤ 2 Liver enzymes ≤2.5 times Under Normal limits or deranged renal functions i.e Creatinine ≤ 1.5 times Under Normal limits

5 Patients with unstable angina or history of Myocardial infarction or underwent CABG

6 Patients with known diagnosis of COPD

7 Pregnant women or women who are breastfeeding
Immunocompromised patients or patients taking immunosuppressant medication or Patients with active malignancy Consideration by the investigator for any reason that the subject is an unsuitable candidate to receive study treatment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of patients progressed to severe stage.

Severe stage defined as
• respiratory distress (≥30 breaths per min);
• oxygen saturation at rest ≤85%;
• severe disease complications (eg, respiratory failure, requirement of mechanical ventilation, septic shock, or non-respiratory organ failure).

 		 Day 0
Till day 10  
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of Pro inflammatory cytokines.
Disease severity on an ordinal scale.
Length of time to clinical improvement and clinical progression
Evaluation of D-dimer
Length of time to normalization of fever, normalization of oxygen
Duration of supplemental oxygen and /mechanical ventilation
Number of participants that developed ARDS
Duration required to get COVID-19 PCR test negative
Duration of hospitalization /or ICU stay
Percent mortality
 		 Till day 10  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/07/2020 
Date of Study Completion (India) 23/12/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Background- The Coronavirus disease (COVID-19) spreads is spreading a great speed and has become a global pandemic. Currently in absence of any approved therapy in India to treat this disease. At present more than 150 different drugs are being researched around the world. Most are existing drugs that are being trialled against the virus. The US Food and Drug Administration (FDA) approved limited emergency use for chloroquine and hydroxychloroquine as a treatment for COVID-19. The National Medical Products Administration of China has approved the use of Favipiravir, an anti-viral drug, as a treatment for coronavirus. However, the use of these investigational drugs has still not showed satisfactory outcomes.

In view of the above scenario there is a scope for use of traditional medicine as an addon complimentary therapy along with standard of care (SoC) to improve therapeutic outcomes in patients with mild to moderate corona virus disease.

Hypothesis: Administration of Ayurveda Rasayana formulation along with standard of care therapies will help improve therapeutic outcomes and prevent progression of the disease to severe stage as compared to patients in control groups receiving standard of care and along with placebo.



 
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