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CTRI Number  CTRI/2025/05/086508 [Registered on: 07/05/2025] Trial Registered Prospectively
Last Modified On: 25/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study on Ayurvedic Treatments (Virechana and Herbal Paste) for skin disease Eczema.  
Scientific Title of Study   A clinical trial to study the efficacy of Virechana and Aragwadh Patra Lepa in the management of Vicharchika w.s.r to 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 Kumari Somi 
Designation  MD (Ay.) Scholar (Dept of Panchkarma) 
Affiliation  Government Ayurvedic College and Hospital 
Address  Government Ayurvedic College and Hospital, Department of Panchkarma, near Buddha Murti, Kadamkuan
Near Buddh Murti, Kadamkuan, Patna- 800003, Bihar
Patna
BIHAR
800003
India 
Phone  9267968139  
Fax    
Email  somisinha6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Akhilesh Prasad Singh 
Designation  Guide and Associate Professor  
Affiliation  Government Ayurvedic College and Hospital 
Address  Government Ayurvedic College and Hospital, Department of Panchkarma, near Buddha Murti, Kadamkuan
Near Buddh Murti, Kadamkuan, Patna- 800003, Bihar
Patna
BIHAR
800003
India 
Phone  8002680973  
Fax    
Email  drapsinghpatna@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Akhilesh Prasad Singh 
Designation  Guide and Associate Professor  
Affiliation  Government Ayurvedic College and Hospital 
Address  Government Ayurvedic College and Hospital, Department of Panchkarma, near Buddha Murti, Kadamkuan
Near Buddh Murti, Kadamkuan, Patna- 800003, Bihar
Patna
BIHAR
800003
India 
Phone  8002680973  
Fax    
Email  drapsinghpatna@gmail.com  
 
Source of Monetary or Material Support  
OPD No. 11,Government Ayurvedic College and Hospital, Kadamkuan, Patna 800003 
 
Primary Sponsor  
Name  Dr Kumari Somi 
Address  Dept of Panchkarma, Government Ayurvedic College and Hospital, near Buddh Murti, Kadamkuan, Patna, Bihar, 800003 
Type of Sponsor  Other [Other (Self)] 
 
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 Kumari Somi  Government Ayurvedic College and Hospital Buddhmurti Kadamkuan, Patna  Department of Panchakarma Government Ayurvedic College and Hospital Kadamkuan Patna [800003]
Patna
BIHAR 		 9267968139

somisinha6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee (IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VICARCIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-lepa, लेप (Procedure Reference: Charak Samhita Chikitsa Sthan 7/96, Procedure details: Aragwadh Patra Lepa will be done on the affected areas.)
2Comparator ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Charak Samhita Chikitsa Sthan 7/44, Procedure details: Virechana with Trivrit Churna will be given.)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age group between 20-60 years.
Sex- Both male and female.
Patients having signs and symptoms of Vicharchika.
Patients indicated for Virechana. 
 
ExclusionCriteria 
Details  Age group below 20 years and above 60 years.
Patients having CAD heart and renal diseases.
Patients receiving major antipsychotic drugs.
Patients unwilling for Virechana.
Patients contraindicated for Virechana.
Patients with Diabetes, AIDS, Hepatitis-B Leukaemia or other systemic illness. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Kandu (Itching)
2. Pidika (Eruption)
3. Shyava/ Vaivarnya ( Depigmentation)
4. Srava (Discharge)
5. Rajyo (Scaling)
6. Ruja (Pain)
7. Rukshata (Dryness) 		 60 Days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Number of Patches
2. Area of Patches 		 60 Days 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 
Date of First Enrollment (India)   01/06/2025 
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="0"
Months="6"
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   This study is a randomized, open, parallel group, interventional prospective trial to study the efficacy of Virechana and Aragwadh Patra Lepa in the management of Vicharchika  w.s.r to Eczema, that will be conducted in Government Ayurvedic Medical College and Hospital at Patna, Bihar in the Department of Panchakarma. In each group of 20 patients,  Virechana Karma will be done and in the another group of 20 patients,  Aragwadh Patra Lepa will be done. Post intervention follow-up will be done every 15 days for total duration of study i.e  60 days. 
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