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CTRI Number  CTRI/2025/03/082836 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 14/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Curative]  
Study Design  Single Arm Study 
Public Title of Study   To evaluate the effect of virechan karma and edgajadi lepa in treatment of vicharchika (eczema) 
Scientific Title of Study   An Open Label Clinical Trial to Evaluate the Therapeutic Efficacy of Virechan Karma Followed by Edgajadi Lepa in The Management of Vicharchika W.S.R. Eczema  
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 Brijesh Rajora 
Designation  MD SCHOLAR 
Affiliation  Pgia,jodhpur,Rajasthan 
Address  PG Department of Panchkarma, Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037 India

Jodhpur
RAJASTHAN
342037
India 
Phone  6377326154  
Fax    
Email  brijesh231rajora@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr GYAN PRAKASH SHARMA 
Designation  Associate professor & HOD 
Affiliation  Post Graduate institute of Ayurveda 
Address  PG Department of Panchkarma, Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037 India

Jodhpur
RAJASTHAN
342037
India 
Phone  9829798701  
Fax    
Email  atreyagyan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Brijesh Rajora 
Designation  MD SCHOLAR 
Affiliation  Post Graduate institute of Ayurveda 
Address  PG Department of Panchkarma, Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037 India

Jodhpur
RAJASTHAN
342037
India 
Phone  6377326154  
Fax    
Email  brijesh231rajora@gmail.com  
 
Source of Monetary or Material Support  
PGIA,JODHPUR,342037,Rajasthan,India 
 
Primary Sponsor  
Name  Post Graduate Institute of Ayurved DSRRAU Jodhpur 
Address  PG Department of Panchkarma Post Graduate Institute of Ayurved DSRRAU Jodhpur 342037 Rajasthan 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 
PGIA JODHPUR RAJASTHAN INDIA  Post graduate institute of ayurved jodhpur,Rajasthan.  PG Department of Panchkarma, Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037 India
Jodhpur
RAJASTHAN 		 6377326154

Brijesh231rajora@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L20-L30||Dermatitis and eczema. Ayurveda Condition: VICARCIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-VIRECHAN KARMA,LEPA (Procedure Reference: CHARAK CHIKITSA 7/44 CHAKRDUTT 50/38, Procedure details: FOR VIRECHANA: Poorva Karma: (Deepan Pachana,Snehapana & Abhyanga/Swedana ) Pradhana Karma: (Virechana Karma) Paschata Karma: (Samsarjana Karma) FOR LEPA Freshly prepared lepa was applied over the affected area in opposite directions of hairs roots. It will then keep for 30 minutes or until it dried. )
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Diagnosed and confirmed cases of Vicharchika (Eczema), on the basis of the sign & symptoms.
2.Patients between the age group of 18-60 years of either sex.
3.Clinically Fit for Virechan karma.
4.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
 
 
ExclusionCriteria 
Details  1.Patients below 18 years and above 60 years of age.
2.Pregnant and lactating woman.
3.Clinically unfit for Virechan.
4.Patient having cardiac disease, renal disease, malignancy and endocrine disorder will exclude from study to avoid overlapping of symptomology.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To reduce redness,scratching,kandu,daha,srava,vaivaranayata,pidikotpatti.  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
To see another effects of this drugs.  60 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)   01/05/2025 
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 Applicable 
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   The Study type is interventional with no of patients selected 30.This is open label study and duration time is 60 days.The main objective of this study is to reduce kandu,daha,srava,rukshata,vaivaranyata and raji.
Virechan and edagajadi lepa will be used in management of vicharchika.

                                                        

 
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