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CTRI Number  CTRI/2020/05/025276 [Registered on: 20/05/2020] Trial Registered Prospectively
Last Modified On: 21/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Trial 
Public Title of Study
Modification(s)  
effect of Ayurvedic intervention in COVID-19 positive cases 
Scientific Title of Study   A Pilot study to estimate the effectiveness of Ayurvedic intervention in COVID-19 positive cases 
Secondary IDs if Any
Modification(s)  
Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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Name  Dr Arun Gupta 
Address  CBPACS, Khera Dabar, New Delhi 110073
Department of Panchakarma Khera Dabar New Delhi
South West
DELHI
110073
India 
Phone  9999155377  
Fax    
Email  arun24@hotmail.com  
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Dr Arun Gupta 
Address  CBPACS, Khera Dabar, New Delhi 110073
Room no 142 department of Panchakarma CBPACS New Delhi
South West
DELHI
110073
India 
Phone  9999155377  
Fax    
Email  arun24@hotmail.com  
 
Details Contact Person
Public Query

Modification(s)  
Name  Dr Arun Gupta 
Address  CBPACS, Khera Dabar, New Delhi 110073
Room no 142 Panchakarma Department CBPACS New Delhi 110073
South West
DELHI
110073
India 
Phone  9999155377  
Fax    
Email  arun24@hotmail.com  
 
Source of Monetary or Material Support
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Ch Brahm Prakash Ayurved Charak Sansthan Autonomous body under GNCTD Khera Dabar New Delhi 110073 
 
Primary Sponsor  
Name  Ch Brahm Prakash Ayurved Charak Sansthan 
Address  Khera Dabar, Najafgarh, New Delhi-110073 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
ProfDr Vidula Gujjarwar  Ch. Brahm Prakash Ayurved Charak Sansthan  Hospital section Khera Dabar, New Delhi 110073
South West
 
9990174348

cbpayurved@gmail.com 
 
Details of Ethics Committee
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No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ch. Brahm Prakash Ayurved Charak Sansthan, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Coronavirus as the cause of diseases classified elsewhere 
 
Intervention / Comparator Agent
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Type  Name  Details 
Intervention  Ayurveda Protocol  1. Sanshamani Vati (Tinospora cordifolia) 1gm BD with 50ml Nagaradi kwath(Decoction of Zingiber officinale -2 part, Terminalia chebula- 4 part, Tinospora cordifolia-6 part in quantity) 2.Amalaki Churna ( Powder of Phyllanthus emblica)3gm with water once a day at 5pm 3.Golden Milk (100ml of milk with 3gm of Curcuma longa) at 9pm. all to be taken orally Duration 14 days 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Willingness to participate in the study and provide the informed consent.
2. Isolated asymptomatic cases that have been tested positive for SARS-CoV2 virus.
 
 
ExclusionCriteria 
Details  1. Cases presenting with severe symptoms of COVID-19.
2. COVID-19 positive cases participating as subjects in the interventional arm of other COVID-19 clinical study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome
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Outcome  TimePoints 
1. Time taken and number of patients progressing from asymptomatic to symptomatic condition.
 
baseline
Daily
14 days 
 
Secondary Outcome
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Outcome  TimePoints 
Time taken to negative conversion of RT-PCR
 
Baseline
10th day
15th day
 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   29/05/2020 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
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Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
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Nil 
Brief Summary
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   Chaudhary Brahm Prakash Ayurved Charak Sansthan (Ayurveda) which is an ISO certified Ayurveda institute is designated as COVID-19 health care center (CHC) on 16.04.2020 vide order no.F.No.PA/SS-II/2020/H&FWSS3hfw/47.

   In this CHC 111 beds are dedicated for managing COVID-19 positive cases up to moderate symptoms. COVID-19 positive cases are referred by government approved COVID-19 testing Centre (CTC) for isolation at Ayurveda.  If patients develop any severe symptoms they are transferred by dedicated ambulance to Lok Nayak Jai Prakash Narayan hospital which is attached as COVID-19 treatment centre.

   This research is aimed to explore the possibility of preventing COVID-19 patients from going to progressive stages of the diseases by using Ayurveda intervention

  Ayurveda Treatment protocol includes Sanshamani vati (AFI part 1, 10/13), Nagaradi kwath (AFI part 1, 4/1), Amalaki churna (API part 1) and Golden milk (milk+ turmeric) which is used to improve the status of Agni and enhancing strength of the patient. These drugs possess antiviral, antimicrobial and immune modulator properties

 

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