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CTRI Number  CTRI/2023/02/049953 [Registered on: 22/02/2023] Trial Registered Prospectively
Last Modified On: 24/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To evaluate the efficacy of traditional Ayurvedic formulation (Divya Melanogrit) in Leukoderma. 
Scientific Title of Study   Efficacy of traditional Ayurvedic formulation (Divya Melanogrit) in Leukoderma: a single arm, open label, observational study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anurag Sharma 
Designation  Ayurvedic Practitioner 
Affiliation  Patanjali Yog Gram 
Address  Patanjali Yog Gram National Highway 58, Yog Gram Road Near Bahadrabad, Haridwar Maharishi, Haridwar, Uttarakhand 249405 Hardwar UTTARANCHAL 249405 India

Hardwar
UTTARANCHAL
249405
India 
Phone  7302254792  
Fax    
Email  clinical.investigator@patanjali.res.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Anurag Sharma 
Designation  Ayurvedic Practitioner 
Affiliation  Patanjali Yog Gram 
Address  Patanjali Yog Gram National Highway 58, Yog Gram Road Near Bahadrabad, Haridwar Maharishi, Haridwar, Uttarakhand 249405 Hardwar UTTARANCHAL 249405 India

Hardwar
UTTARANCHAL
249405
India 
Phone  7302254792  
Fax    
Email  clinical.investigator@patanjali.res.in  
 
Details of Contact Person
Public Query  
Name  Dr Anurag Sharma 
Designation  Ayurvedic Practitioner 
Affiliation  Patanjali Yog Gram 
Address  Patanjali Yog Gram National Highway 58, Yog Gram Road Near Bahadrabad, Haridwar Maharishi, Haridwar, Uttarakhand 249405 Hardwar UTTARANCHAL 249405 India

Hardwar
UTTARANCHAL
249402
India 
Phone  7302254792  
Fax    
Email  clinical.investigator@patanjali.res.in  
 
Source of Monetary or Material Support  
Patanjali Research Institute governed by Patanjali Research Foundation Trust 
 
Primary Sponsor  
Name  Patanjali Research Institute governed by Patanjali Research Foundation Trust 
Address  Patanjali Research Institute Near Patanjali Yogpeeth 1, NH 58 Haridwar, Uttarakhand 249405  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Purva Soni  Patanjali Wellness Center  Phase II, Delhi-Haridwar National Highway, Near Bahadrabad, Haridwar-249405. Uttarakhand, India
Hardwar
UTTARANCHAL 		 8272068141

purvasoni92@gmail.com 
Dr Anurag Sharma  Patanjali Yoggram  Patanjali Yog Gram National Highway 58, Yog Gram Road Near Bahadrabad, Haridwar Maharishi, Haridwar, Uttarakhand 249405
Hardwar
UTTARANCHAL 		 7302254792

clinical.investigator@patanjali.res.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan  Approved 
Institutional Ethics Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan  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 ArmDrugOther than Classical(1) Medicine Name: Melanogrit, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 540(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients who are known cases of leukoderma (vitiligo).
2. Age should be minimum of 18 years.
3. Patient who is willing to participate voluntary and comply throughout the study process.
4. Informed consent must be obtained
 
 
ExclusionCriteria 
Details  CRITERIA FOR INCLUSION AND EXCLUSION
Inclusion criteria
1. Patients who are known cases of leukoderma (vitiligo).
2. Age should be minimum of 18 years.
3. Patient who is willing to participate voluntary and comply throughout the study process.
4. Informed consent must be obtained.
Exclusion criteria
1. Patients who do not fulfill inclusion criteria must be excluded.
2. Known cases of Psoriasis, eczema or any other skin allergies patients will be excluded.
3. Patients who are currently undergoing any restricted therapy like UV phototherapy, Tar therapy, topical photo chemotherapy, oral and topical corticosteroids, immunomodulators, etc. will be excluded.
4. Patients who are pregnant, lactating and those who plan to become pregnant within a year.
5. Those with a history of primary cardiovascular, respiratory, digestive, urinary, endocrinological and haematological diseases that cannot be controlled with ordinary treatments will be excluded.
6. Those with malignant diseases, infections, electrolyte imbalances and acid-base disturbances will be excluded.
7. Patients who are allergic to any medicine or ingredients used in this study will be excluded.
8. Patients who are consuming steroids during the study duration must be excluded.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness and tolerability of Divya Melanogrit in patients with Leukoderma.  Baseline, 12 weeks, 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
• Changes in the Vitiligo Extent Score (VES), Investigators Global Assessment (IGA), VIS-22, VitiQol and Global perceived treatment satisfaction from medication.

 		 DAY 0, DAY 90,DAY 180 
 
Target Sample Size   Total Sample Size="81"
Sample Size from India="81" 
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 3 
Date of First Enrollment (India)   23/02/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 single-arm, open-label, observational study.The sample size of the study is 81.Patients above the age of 18 will be enrolled. Participants will receive interventions for 6 months. The primary objective is to evaluate the efficacy and tolerability of 540 mg BID Melanogrit (Traditional Indian Ayurvedic Medicine) in patients with Leukoderma and secondary outcome is changes in the Vitiligo Extent Score (VES), Investigators Global Assessment (IGA), VIS-22, VitiQol and Global perceived treatment satisfaction from medication. 
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