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CTRI Number  CTRI/2020/07/026570 [Registered on: 14/07/2020] Trial Registered Prospectively
Last Modified On: 02/12/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Safety and efficacy of Ayurvedic Capsule in mild to moderate COVID-19 infection. 
Scientific Title of Study   A double blind randomized controlled trial to assess safety and efficacy of Cap. IP in COVID-19 positive patients with mild to moderate severity for early recovery, in restoring respiratory health and in improvement in innate immunity 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kishor H Suryawanshi 
Designation  Professor & Head 
Affiliation  Yashwantrao Chavan Memorial Hospital 
Address  Departmet Of Pathology, Yashwantrao Chavan Memorial Hospital, YCM Hospital Rd,
Sant Tukaram Nagar, Pimpri Colony,
Pune
MAHARASHTRA
411018
India 
Phone  9403424244  
Fax    
Email  drkishorsuryawanshi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suresh Patankar 
Designation  Co-Investigator and Consultant 
Affiliation  Quest Clinical Services 
Address  Ace Hospital, Survey No 32/2 A,
Gulawani Maharaj Road, Erandwane,
Pune
MAHARASHTRA
411051
India 
Phone    
Fax    
Email  sureshpatankar51@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Hrishikesh Rangnekar 
Designation  Co-Investigator 
Affiliation  Quest Clinical Services 
Address  D 204, Sun Planet, Sun city,
Anand Nagar,
Pune
MAHARASHTRA
411051
India 
Phone  9890901109  
Fax    
Email  dr.rangnekar@gmail.com  
 
Source of Monetary or Material Support  
AMAI Charitable Trust, Pune 
 
Primary Sponsor  
Name  AMAI Charitable Trust Pune  
Address  Shop No 4 S No 8/4/1 Lane No 4 Yashawant Apartment Karve Nagar 411052 
Type of Sponsor  Other [A Charitable Trust] 
 
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 
Susmita Wani  Yashwantrao Chavan Memorial Hospital  YCM Hospital Rd, Sant Tukaram Nagar, Pimpri Colony, Pune
Pune
MAHARASHTRA 		 8793930577

susmitawani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
YCMH Ethics Committee  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  Cap. IP  Ayurvedic formulation to be taken twice daily in addition to standard of care 
Comparator Agent  Placebo  Capsule to be taken twice daily in addition to standard of care 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Age > 18 years
2.All sexes
3.Case definitions for inclusion in the study will include mild to moderately severe cases as defined in the Guidance on appropriate treatment of suspect/confirmed case of COVI19 issued by Ministry of Health and Family Welfare, Govt of India on 07 Apr 2020.
Mild: Cases presenting with fever and/or upper respiratory tract illness (Influenza like Illness, ILI); Moderate: Pneumonia with no signs of severe disease (Respiratory Rate 15 to 30/minute, SpO2 90%-94%). OR
4.Laboratory confirmed SARS CoV-2 infection within last 10 days or SARS CoV-2 test result pending with a high clinical suspicion as defined by: Cough of more than 10 days duration OR
5.Bilateral pulmonary infiltrates on chest X Ray / CT scan or new hypoxaemia defined as SpO2 <94% on room air, where no alternative explanation for respiratory symptoms can be given
 
 
ExclusionCriteria 
Details  1.Pregnant or lactating women
2.Symptoms of acute respiratory tract infection for more than seven days
3.More than 48 hours have elapsed between meeting inclusion criteria and enrolment
4.Subject is also a participant of any other clinical trial
5.Serious / long-standing co-morbid conditions
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Efficacy of Cap. IP (500 mg) in boosting innate immunity of patients with COVID-19 infection in one months duration.  1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Efficacy of Cap. IP in restoring respiratory health  1 Month 
Efficacy of Cap. IP in early recovery of patients  1 Month 
Assessing safety of Cap. IP   1 Month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2020 
Date of Study Completion (India) 03/09/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Protocol got published in BioMed Central, on 23 Nov 2020. Results are yet to be published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  
COVID -19 is a respiratory illness that has led to a pandemic, affecting more that 200 countries in the world. Due to sudden advent and rapid spread of infection, no antiviral drug has been found to be effective since its onset. (Tab. Favipiravir is approved though, it’s efficacy in population at large, in real-world setting is yet to be confirmed)

While there is no medicine for COVID-19 as of now, enhancing the body’s immunity should play an important role in maintaining optimum health and the IP (study drug) might possibly play an important role in enhancing immunity. The capsule contains ghana of Withania somnifera, Terminalia chebula, Tinospora cordifolia, Asparagus racemosus, Emblica officinalis etc. 

Role of study drug as an antiviral will also be tested by frequent naso-pharyngeal and oro-pharyngeal swabs.

This is prospective, double blind study aims to assess the efficacy and safety of Cap. IP in the management of COVID 19 patients and also in boosting innate immunity. Secondary objectives are,  to assess efficacy of Cap. IP in restoring respiratory health, in early recovery of patients and to assess safety of Cap. IP. 

Trial Overview
Total 72 patients were enrolled in the study.1st patient was enrolled on 11 Aug 2020 and Last patient was enrolled on 3 Sep 2020.Follow up visits completed on 5 Oct 2020. 
Protocol published under BMC.
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