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CTRI Number  CTRI/2023/03/050278 [Registered on: 02/03/2023] Trial Registered Prospectively
Last Modified On: 28/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Randomized, Clinical Study to Evaluate the Efficacy and Safety of Roghan-i-Baras in management of Baras(Vitiligo) 
Scientific Title of Study   A Randomized, Parallel group, Open Label, Active controlled Clinical study to Evaluate the Efficacy and Safety of Roghan-i-Baras in the management of Baras (Vitiligo) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mohd Ashik 
Designation  PG Scholar 
Affiliation  National Research Institute Of Unani Medicine For Skin Disorders 
Address  Department Of Moalajat, National Research Institute Of Unani Medicine For Skin Disorders, A.G. Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad-500038 India

Hyderabad
TELANGANA
500038
India 
Phone  9005370209  
Fax    
Email  ansariashiq891@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Arzeena Jabeen 
Designation  Professor 
Affiliation  National Research Institute Of Unani Medicine For Skin Disorders 
Address  Department Of Moalajat, National Research Institute Of Unani Medicine For Skin Disorders, A.G. Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad-500038 India

Hyderabad
TELANGANA
500038
India 
Phone  9032519286  
Fax    
Email  aarzu763@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mohd Ashik 
Designation  PG Scholar 
Affiliation  National Research Institute Of Unani Medicine For Skin Disorders 
Address  Department Of Moalajat, National Research Institute Of Unani Medicine For Skin Disorders, A.G. Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad-500038 India

Hyderabad
TELANGANA
500038
India 
Phone  9005370209  
Fax    
Email  ansariashiq891@gmail.com  
 
Source of Monetary or Material Support  
National Research Institute Of Unani Medicine For Skin Disorders,AG colony road, Erragadda,Hyderabad 
 
Primary Sponsor  
Name  National Research Institute Of Unani Medicine For Skin Disorders 
Address  A.G. Colony Road, Opposite ESI Hospital, Erragadda, Hyderabad-500038 
Type of Sponsor  Research institution and hospital 
 
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 Mohd Ashik  National Reasearch Institute Of Unani Medicine For skin Disorders  OPD of Department of Moalajat, New OPD Block, National Research Institute of Unani Medicine for Skin Disorders A G Colony Road, Opposite ESI Hospital, Erragadda, Hyderabad 500038 Hyderabad TELANGANA
Hyderabad
TELANGANA 
9005370209

ansariashiq891@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical Committee, NRIUMSD, Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L80||Vitiligo,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Methoxsalen 1%   Dosage Form: Ointment Dose: Applied locally As Per Required once in the morning Duration: 16 weeks 
Intervention  Roghan-i-Baras  Dosage Form: Oil Dose : To be applied locally as per required once in the morning Duration: 16 weeks Composition 1. Post Baikh Sheetraj Hindi Plumbago zeylancia Linn. 10 gm 2. Tankar (Suhaga) Sodium borate (Decahydrate) 10 gm 3. Ghungchi safaid Abrus precatorius Linn. 10 gm 4. Roghan-e-kunjad Sesamum indicum Linn. 250 ml 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.The participants will be included in the study on the basis of the following
criteria:
2.Subjects of any sex aged 18-60 years
3.Non-Segmental Vitiligo with Chronicity of 6 months to 3 years
4.Subjects with <5 new lesions in the last month, atleast 1% body surface
area.
5.Subjects with <15 lesions in the last 3 months, atleast 1% body surface
area.
6.Subjects who have not taken systemic treatment in the last 4 weeks
7.Subjects who have not taken topical treatment in the last 2 weeks
8.Participants who are able and willing to comply with the protocol and to sign IEC approved ICF 
 
ExclusionCriteria 
Details  The following patients will be excluded
•Patients aged <18 years or >60 years
•Segmental Vitiligo/ Lip-Tip/ Universal Vitiligo
•History of photosensitivity/ photo exaggerated dermatoses and Connective Tissue Diseases
•Pregnant or Lactating Women
•Significant Cardiovascular/ Pulmonary/ Hepato-renal Dysfunction
•Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies (cutaneous or internal)
•Patients not willing to attend treatment schedule regularly
•Patients not having a suitable facility for sun exposure.
•Any other clinical condition that in the opinion of the investigator would compromise the patient’s safety or successful participation in the trial.
•Known allergy, sensitivity or intolerance to the study drug or any of its ingredients
•Participants with active alcohol intake and/or drug abuse
•Participants not willing to sign the ICF and to attend treatment schedule regularly. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Reduction in Vitiligo Area Scoring Index (VASI)
2.Change in Vitiligo Disease Activity (VIDA) Score.

3.Improvement in Global Assessment (IGA)
4.Photographic Assessment 
4th,8th,12th and 16th week 
 
Secondary Outcome  
Outcome  TimePoints 
Systemic safety Assessment  4th,8th,12th and 16th 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/ Phase 3 
Date of First Enrollment (India)   10/03/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Vitiligo is a cosmetic dermatological defect, but it has a very prominent social and psychological impact on the patient. It is a depigmenting skin disorder characterized by the selective loss of melanocytes, which in turn leads to pigment dilution in the affected area of the skin. The characteristic lesion is totally amelanotic, non-scaly, chalky-white macule with distinct margins. Vitiligo is a common dermatological as well as cosmetic and social problem with prevalence 1% to 2% of the world population .In India it is between 3% to 4%The incidence of vitiligo as reported by various workers in different cities of India can be 2.9% in Goa, 8.8% in Delhi. However most authors say that its incidence is around is 4% which is however definitely more as compared to worlds population of 1%. Several single and compound formulations have been used to treat vitiligo by many ancient Unani physicians, but some of them are not yet scientifically evaluated on modern parameters. Hence, this A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study is planned to evaluate the Efficacy and Safety of Roghan-i-Baras in the Management of Baraá¹£ (Vitiligo). Participants fulfilling inclusion and exclusion criteria will receive either test or control drug as per randomization. In test group participants will start with Roghan-i-Baras and in control group participants will start with Methoxsalen 1% , for the duration of 16 weeks. Baseline and last follow up and laboratory investigations will be done. 

Statistical analysis : After completion of the study, data obtained will be analysed statistically by using an appropriate statistical test to evaluate the significance of results. p<0.05 will be considered significant.

 
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