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CTRI Number  CTRI/2023/08/057111 [Registered on: 31/08/2023] Trial Registered Prospectively
Last Modified On: 01/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Agnikarma for the management of wart 
Scientific Title of Study   A comparative study of Agnikarma by Rajat Shalaka versus Tamra Shalaka in the management of Charmakeel. 
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 Rahul Kumar Verma 
Designation  P.G. Scholar Shalya Tantra 
Affiliation  Government P.G. Ayurvedic College and Hospital, Varanasi  
Address  OPD No-25, Shalya Tantra Department, Government P.G. Ayurvedic College and Hospital, Varanasi

Varanasi
UTTAR PRADESH
221002
India 
Phone  08445718376  
Fax    
Email  rahuldgreat05@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suman Yadav 
Designation  Reader and HOD 
Affiliation  Government P.G. Ayurvedic College and Hospital, Varanasi  
Address  OPD No-25, Shalya Tantra Department, Government P.G. Ayurvedic College and Hospital, Varanasi

Varanasi
UTTAR PRADESH
221002
India 
Phone  9451965767  
Fax    
Email  yadavsuman06022073@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suman Yadav 
Designation  Reader and HOD 
Affiliation  Government P.G. Ayurvedic College and Hospital, Varanasi  
Address  OPD No-25, Shalya Tantra Department, Government P.G. Ayurvedic College and Hospital, Varanasi

Varanasi
UTTAR PRADESH
221002
India 
Phone  9451965767  
Fax    
Email  yadavsuman06022073@gmail.com  
 
Source of Monetary or Material Support  
Government P.G. Ayurvedic College and Hospital, Varanasi 
 
Primary Sponsor  
Name  Government P.G. Ayurvedic College and Hospital, Varanasi 
Address  OPD No-25, Shalya Tantra Department, Government P.G. Ayurvedic College and Hospital, Varanasi, Uttar Pradesh 221002 
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 
OPD No Shalya Tantra Department Government PG Ayurvedic College and Hospital Varanasi  Government P.G. Ayurvedic College and Hospital Varanasi  OPD No 25 Shalya Tantra Department Government P.G. Ayurvedic College and Hospital Varanasi
Varanasi
UTTAR PRADESH 		 8445718376

rahuldgreat05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Ayurveda College and Hospital, Varanasi, U.P. Mahayogi Guru Gorakhath AYUSH University, Gorakhpur, U.P.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: CARMAKILAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Sushruta Samhita Sutrasthana 12, Procedure details: The site of Agnikarma is washed with Triphala Kwatha and wiped with dry sterilized gauze and covered with a cut sheet. Rajat Shalaka was heated up to red hot and make samyak dagdha over the wart after that apply aloevera pulp kept ready for dressing, duration per week. Follow Up 7 Days)
2Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Sushruta Samhita Sutrasthana 12, Procedure details: The site of Agnikarma is washed with Triphala Kwatha and wiped with dry sterilized gauze and covered with a cut sheet. Tamra Shalaka was heated up to red hot and make samyak dagdha over the wart after that apply aloevera pulp kept ready for dressing, duration per week. Follow Up 7 Days)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients suffering from Charmakeel will be taken.
2. Patients have no pre-existing serious medical condition.
3. Person currently taking no other medication.
 
 
ExclusionCriteria 
Details  1. Age below 18 years and above 60 years
2. Any serious systemic disorders like Tuberculosis, Hypertesion, Diaetic melliatus etc
3. Pregnant women
4. Mentally sick patient
5. HIV, HBsAg, HCV Positive cases
• Warts associated with other complication.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decrease in size with relief in pain   14 Days (with in two weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
Size of Charmakeel reduction with pain relief & resolution of all symptoms  21 to 28 Days (three weeks to four weeks) 
 
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   Phase 2 
Date of First Enrollment (India)   10/10/2023 
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="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
Interventional Study



Pateint suffering from Charmakeel will be selected from OPD of Shalya Tantra Department on Government P.G. Ayurvedic College and Hospital, Varanasi



Total Patient = 60



The site (Wart) of Agnikarma is washed with Triphala Kwatha and wiped with dry sterilized gauze and covered with a cut sheet. Shalaka was heated up to red hot (Rajata Shalaka and Tamra Shalaka) in randomized manner and make samyak dagdha over the wart after that apply aloevera pulp kept ready for dressing, duration per week.



Follow Up = 7 Days


 
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