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CTRI Number  CTRI/2020/10/028570 [Registered on: 22/10/2020] Trial Registered Prospectively
Last Modified On: 21/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To study the effect of Vyaghradi Kashay tablet on COVID-19 patients 
Scientific Title of Study   An interventional, single arm study to observe and assess the effectiveness of “Vyaghradi Kashaya Tab” in preventing the progression of severity in asymptomatic, mild to moderate COVID-19 cases. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manoj Shamkuwar 
Designation  Associate Professor and HOD Dept of Panchakarma 
Affiliation  A and U Tibbia College and Hospital Govt of NCT of Delhi 
Address  Department of Panchakarma A and U Tibbia College and Hospital Karol Bagh

New Delhi
DELHI
110005
India 
Phone    
Fax    
Email  manoj_1873@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manoj Shamkuwar 
Designation  Associate Professor and HOD Dept of Panchakarma 
Affiliation  A and U Tibbia College and Hospital Govt of NCT of Delhi 
Address  Department of Panchakarma A and U Tibbia College and Hospital Karol Bagh

New Delhi
DELHI
110005
India 
Phone    
Fax    
Email  manoj_1873@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Nitin Jindal 
Designation  Assistant Professor  
Affiliation  A and U Tibbia College and Hospital 
Address  Department of Panchakarma A and U Tibbia College and Hospital Karol Bagh

New Delhi
DELHI
110005
India 
Phone    
Fax    
Email  nitjin2005@gmail.com  
 
Source of Monetary or Material Support  
A and U TIbbia College and Hospital Govt of NCT of Delhi 
 
Primary Sponsor  
Name  Ministry of AYUSH Govt of India 
Address  GPO Complex, AYUSH BHAWAN, B Block, INA Colony, New Delhi, Delhi 110023 
Type of Sponsor  Other [Ministry of AYUSH Govt of India] 
 
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 Nitin Jindal  A and U Tibbia College and Hospital Govt of NCT of Delhi  COVID Ward - Maternity Block Ajmalkhan Road Karol Bagh
New Delhi
DELHI 
9354925045

nitjin2005@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ayurvedic and Unani College and Hospital, Govt of NCT of Delhi  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 
Comparator Agent  Not applicable  Not applicable 
Intervention  Vyaghradi Kashay Tablet  Drug- Vyaghradi Kashay Tablet Dose : One tab(500mg)three times a day with luke warm water Route -Oral Duration - 7 days (Initially). If RTPCR Not negative in 7 days it will continue up to 14 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  People who have been tested positive to be infected with SARS-CoV2 virus and presenting with no symptoms or with mild to moderate symptoms.
All the patients of age group 18-65 yrs
All those who are willing to give written consent for participation in the study
 
 
ExclusionCriteria 
Details  COVID patients with symptoms classified as severe or critical.
Persons with severe primary respiratory disease or other pneumonia
Pregnant and lactating women
Persons with serious complications of diseases such as cancer, heart disease, stroke, disabilities, mental illnesses, etc., and who are considered to be excluded from the study as evaluated by the investigators
COVID-19 positive cases participating as subjects in the interventional arm of other COVID-19 clinical trials.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Time taken to be tested negative for SARS-CoV2 in RT-PCR.
To Assess the effect of drug in preventing the progression of severity of symptoms. 
a)RT PCR 7th and 14th Day
b)Assessment of clinical recovery at baseline, Daily 7-14 days
 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome-
To assess the effect of Vyaghradi Kwath Tab on blood parameters specific to Covid-19.
 
08-15 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2/ Phase 3 
Date of First Enrollment (India)   05/11/2020 
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="3"
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  

Coronavirus (COVID-19) is a pandemic started from Wuhan City of  China in December 2019, with the case of Pneumonia with unknown cause later on in the mid of January 2020 it was declared as an emergency. There are Numerous studies have been published, establishing evidence and opinion-based guides current COVID-19 pandemic, which has taken the world by storm. The sudden outbreak of COVID-19 making society of the people realizes the threat of communicable diseases to human being. A whole-of-society approach is needed to tackle 21st century epidemics so that all the different type of epidemic disease is to be taken into consideration. Genetics and biological factors, ecology and the physical environment; are also affecting causes. This increasing convergence of many factors that requires multi-disciplinary, multi-sectoral and multi-faceted approaches. Ayurved can be helpful in pandemic disease like COVID-19. In COVID patients Cough and sputum, Chest tightness, Difficulty breathing, Fever, Fatigue, Nasal congestion, runny nose, Sick and vomiting are the common symptoms. Vyaghradi Kashaya is indicated in Vatshleshmak jwara having the symptoms like cough, running nose, breathlessness. Therefore, the proposed study is designed to search out the effectiveness of Vaghradi Kashay in asymptomatic and mild to moderate cases of COVID-19. The composition of the drug is Kantakari (Solanum xanthocarpum), Sunthi (Zingiber officinale), Amruta (Tinospora cordifolia), Pippali (Piper longum).These drugs have antiviral, antibacterial, antioxidant and immunomodulator property.

 
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