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CTRI Number  CTRI/2024/09/074241 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 25/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use Of Leech Therapy And Aaragvadhadi Taila In The Management Of Vitilgo 
Scientific Title of Study   A Clinical Study To Evaluate The Eficacy Of Jalouka Avacharana And Aaragvadhadi Taila In The Management Of The Shwitra Wsr To Vitilgo 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  DR Suman Kumari Damor 
Designation  Pg Scholar 
Affiliation   
Address  SHALYA TANTRA DEPARTMENT Madan Mohan Malviya Government Ayurved College Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  7296904130  
Fax    
Email  sumanudr11@gmail.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Namo Narayan Meena 
Designation  Associate professor 
Affiliation   
Address  Shalya Tantra Department Madana Mohan Malviya Government Ayurved College Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9928871125  
Fax    
Email  drnamorajat@gmail.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Namo Narayan Meena 
Designation  Associate proffesor 
Affiliation   
Address  Shalya Tantra Department Madan Mohan Malviya Government Ayurved College Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9928871125  
Fax    
Email  drnamorajat@gmail.com  
 
Source of Monetary or Material Support  
Madan Mohan Malviya Government Ayurved College Ambamata Udaipur Rajasthan India 313001 
 
Primary Sponsor  
Name  MMM Government Ayurved College Ambamata Udaipur Rajasthan 
Address  MMM Government Ayurved College Udaipur Rajasthan 313001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
MMM Government Ayurved College Udaipur Rajasthan  MMM Government Ayurved College Udaipur Rajasthan 313001 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suman Kumari Damor  MMM Government Ayurved College Udaipur Rajasthan  Opd 1 ShalyaTantra Department MMM Government Ayurved College Udaipur Rajasthan 313001
Udaipur
RAJASTHAN 		 7296904130

sumanudr11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee MMM Govt Ayurved College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: SVITRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-jalaukAvacaraNam, जलौकावचरणम् Pradhan Karma(Procedure Reference: Charak Samhita, Procedure details: 6 Sitting Jalouka Avacharana At The Interval Of 7 Day)
2Comparator ArmProcedure-jalaukAvacaraNam, जलौकावचरणम् (Procedure Reference: charak samhita, Procedure details: 6 sitting of jalouka-avacharana at the interval of 7 days & aaragwadhadi taila daily up to trial time period)
(1) Medicine Name: Aragwadhadi Taila, Reference: Chakradutta, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 6 Weeks
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient having clinical sign and symptoms of Shwitra
Duration of the disense being less than one year
Age between 16-60 years
Sex both male and female
Patient who are willing to participate in the study
Those ready to give written informed consent
Jalouka-avacharana yogya patients as per classics text
Patient having Size of patches up to 10 cm²
Patient having no of patches up to 4. 
 
ExclusionCriteria 
Details  Patients who are not agree for written consent
Duration of the disease more than one year
HIV, HBsAg positive patient.
Uncontrolled diabetes mellitus
Hypertension.
Not willing undergo trial
Jalouka-avacharana ayogya patients as per classics text
Age below 16 year and above 60 years.
Patient having Size of patches more than 10 cm³
Patient having No of patches more than 4 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assesment Of Size Of Patches
Assesment Of No Of Patches
Assesment Of Color Of Skin
Assesment Of Color Of Hair
Assesment Of Dryness
Assesment Of Burning Sensation
Assesment Of Itching
Assesment Of Hair Fall On Affected Area 		 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Assesment Of Vitilgo Patches Reduction  6 week 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   31/10/2024 
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  clinical study  To Evaluate The Efficacy Of jalaukavacharna and Aaragavadhadi Taila in the management of the Shwitra w.s.r. To Vitiligo.there will be 2 group in the study ,in group A
randomly selected and clinically diagnosed 20 patient of Shwitra(Vitiligo) .group A will be given  intervention by jalaukavacharana ,and 20 patientof group B randomly selected and clinicaly
diagnose will be apply jalaukavacharna along with  Aaragavadhadi Taila  trial will be conducted for a period of 6 weeks .follow up of the case will be done after completion of 6 Weeks course on the basis of primary and secondary outcomes. The data will be analyzed scientifically and statiscally.
 
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