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CTRI Number  CTRI/2022/06/042983 [Registered on: 02/06/2022] Trial Registered Prospectively
Last Modified On: 24/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic management of Switra (Vitiligo) in children 
Scientific Title of Study   Clinical study to evaluate the combined effect of Harataladi lepa and Bakuchi churna capsule in the management of Switra (Vitiligo) in children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rekha B Pattar 
Designation  Post graduate scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 
Address  Room no. 16, Department of Kaumarabhritya
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka
Hassan
KARNATAKA
573201
India 
Phone  8951482362  
Fax    
Email  rekhapattar6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arun Raj GR 
Designation  Assistant Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 
Address  Room no. 16, Department of Kaumarabhritya
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka
Hassan
KARNATAKA
573201
India 
Phone  9886292826  
Fax    
Email  drdrarunraj26@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arun Raj GR 
Designation  Assistant Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 
Address  Room no. 16, Department of Kaumarabhritya
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka
Hassan
KARNATAKA
573201
India 
Phone  9886292826  
Fax    
Email  drdrarunraj26@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 
Type of Sponsor  Private 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 Rekha B Pattar  Sri Dharmasthala Manjunatehswara College of Ayurveda and Hospital, Hassan  Room no.16, Department of Kaumarabhritya
Hassan
KARNATAKA 		 8951482362

rekhapattar6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDM College of Ayurveda and Hospital, Hassan  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 ArmDrugClassical(1) Medicine Name: Harataladi lepa, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1.6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Bakuchi capsule, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Warm water), Additional Information: -
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1. The children of either gender between the age group of 6-16 years fulfilling the diagnostic criteria of Vitiligo.
2. Children, whose parents are willing to participate them in the study after giving informed parent consent.
 
 
ExclusionCriteria 
Details  1. Vitiligo patches developed as a complication of burns.
2. Children diagnosed with autoimmune disorders, neurological disorders, endocrine disorders, leprosy and tuberculosis.
3. Children with universal vitiligo and mucosal vitiligo.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The increase in pigmentation of Vitiligo patches will be measured before ad after intervention  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in the size of Vitiligo patches  30 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 
Date of First Enrollment (India)   06/06/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rekhapattar6@gmail.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 31-12-2025?
    Response (Others) -  One year post publication

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The objective of the study is to evaluate the combined effect of Harataladi lepa and Bakuchi churna cpasule in Switra (Vitiligo) in children. 30 subjects with Switra will be administered with Bakuchi capsule internally along with application of Harataladi lepa externally for a period of 30 days. The subjects will be assessed for primary outcome measures on 0th day, 31st day and 61st day. 
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