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CTRI Number  CTRI/2025/02/081459 [Registered on: 28/02/2025] Trial Registered Prospectively
Last Modified On: 15/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Comparison of liver function in post COVID and healthy individuals. 
Scientific Title of Study   A study to evaluate the post COVID effect on yakrit karma(liver function)- A case control study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr C Devaki Krishna 
Designation  PG Scholar, Department of Rog Nidan Evam Vikriti Vigyan 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Department of Rog Nidan Evam Vikriti Vigyan,Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar,Najafgarh,South West Delhi,110073 India

South West
DELHI
110073
India 
Phone  8086825710  
Fax    
Email  drdevakikrishna@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Vidula Gujjarwar 
Designation  Professor and HOD 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Department of Rog Nidan Evam Vikriti Vigyan,Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar,Najafgarh,South West Delhi,110073 India

South West
DELHI
110073
India 
Phone  9990174348  
Fax    
Email  Shreemahalaxmi1969@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Vidula Gujjarwar 
Designation  Professor and HOD 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Department of Rog Nidan Evam Vikriti Vigyan,Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar,Najafgarh,South West Delhi,110073 India

South West
DELHI
110073
India 
Phone  9990174348  
Fax    
Email  Shreemahalaxmi1969@gmail.com  
 
Source of Monetary or Material Support  
Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, South West Delhi, 110073, India. 
 
Primary Sponsor  
Name  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, South West Delhi, 110073, India. 
Type of Sponsor  Government medical college 
 
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 C Devaki Krishna  Chaudhary Brahm Prakash Ayurved Charak Sansthan  Department of Rog Nidan Evam Vikriti Vigyan,Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar,Najafgarh,South West Delhi,110073 India
South West
DELHI 		 8086825710

drdevakikrishna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethical Committee- Chaudhary Brahm Prakash Ayurved Charak Sansthan (CBPACS)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy volunteers 
Patients  (1) ICD-10 Condition:U071||COVID 19 virus identified. Ayurveda Condition: JVARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  GROUP 1- patients with history of COVID 2020-2021 onwards selected from CBPACS OPD/IPD.
GROUP 2- Healthy individuals. 
 
ExclusionCriteria 
Details  Individuals diagnosed with hepatic diseases(fatty liver, cirrhosis, hepatitis, liver failure).
History of alcohol intake
Individuals on steroidal medication. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare liver function in post COVID and healthy individuals.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
if derangement seen in Liver Function, to bring awareness and counsel individuals on preventing further damage in liver function.  1 year 
 
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   N/A 
Date of First Enrollment (India)   01/03/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   COVID-19, an emergency to the world as declared by the WHO is the burning crisis all over the world. The topic holds the utmost relevance in the present scenario. Millions of people have been affected and more will continue to be infected, the number of "long-haulers" being dramatically increasing. This makes it crucial to understand the heterogeneity of post-COVID conditions. This viral infection can lead to the destabilization of the liver, which signals a state of maximum alertness of the whole organism, generating an increase in plasma biochemical markers of tissue aggression produced in response to tissue-damaging agents.  The liver is the center of the metabolism of nutrients and excretion of waste products- thereby providing protection against foreign substances by detoxifying and eliminating them. all these point to the importance of yakrit karma(liver function) in post-COVID condition to ensure healthy living. 
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