CTRI Number |
CTRI/2025/03/081572 [Registered on: 03/03/2025] Trial Registered Prospectively |
Last Modified On: |
25/02/2025 |
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
|
clinical study to evaluate the safety and efficacy of Dimad e baras in baras (Vitiligo) |
Scientific Title of Study
|
A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study To Evaluate The Safety And Efficacy Of Dimad-E- Baras (Topical) Compared With Methoxasalen 1 Percent(Topical) In The Management Of Baras (Vitiligo) |
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 Hina Kausar |
Designation |
PG Scholar |
Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
Address |
National Research Institute Of Unani Medicine For Skin Disorders
Department of Moalajat
AG Colony Road, opp. ESI Hospital, Erragadda, 500038
Hyderabad Telangana
Hyderabad TELANGANA 500038 India |
Phone |
7972260177 |
Fax |
|
Email |
hinakausarhd@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Ashfaque Ahmed |
Designation |
Reader |
Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
Address |
National Research Institute Of Unani Medicine For Skin Disorders
Department of Moalajat
AG Colony Road, opp. ESI Hospital, Erragadda, 500038
Hyderabad Telangana
Hyderabad TELANGANA 500038 India |
Phone |
8103161174 |
Fax |
|
Email |
drashfaque6@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Hina Kausar |
Designation |
PG Scholar |
Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
Address |
National Research Institute Of Unani Medicine For Skin Disorders
Department of Moalajat
AG Colony Road, opp. ESI Hospital, Erragadda, 500038
Hyderabad Telangana
TELANGANA 500038 India |
Phone |
7972260177 |
Fax |
|
Email |
hinakausarhd@gmail.com |
|
Source of Monetary or Material Support
|
National Research Institute of Unani Medicine for Skin
Disorders
AG Colony Road, Opp. ESI Hospital, Erragadda, 500038 Hyderabad |
|
Primary Sponsor
|
Name |
National Research Institute of Unani Medicine for Skin Disorders |
Address |
A.G. Colony Road, Opposite E.S.I. Hospital,Erragadda, Hyderabad-500038 |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Hina Kausar |
National Research Institute of Unani Medicine for Skin Disorders |
OPD and IPD of NRIUM SD ,Department of Moalajat, A.G.Colony Road, Opposite E.S.I. Hospital, Erragadda, Hyderabad-500038 Hyderabad TELANGANA |
7972260177
hinakausarhd@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Communication of Dissertation of Institutional Ethics Committee(IEC) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Dimad-e-Baras |
Dimad-e-Baras containing Bekh-e-Anjeer Dashti, Babchi ,Tukhm-e-Panwar, Narkachor ,Abe lemu will be used topically on vitiliginous lesions followed by sun exposure daily once. |
Comparator Agent |
Methoxsalen 1 % Solution |
Apply Methoxsalen 1 % Solution topically on vitiliginous lesions followed by sun exposure. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Participants having Non segmental vitiligo with Chronicity of 6 months to 3 years
2.Vitiligo involving more than 2 percent Body Surface Area (BSA)
3.Participants with less than 5 new lesions in the last month
4.Participants with less than 15 lesions in the last 3 months
5.Participants who have not taken systemic and tropical treatment in the last 4 week
|
|
ExclusionCriteria |
Details |
1.Participants aged less than 18 years or more than 60 years
2.Participants with Segmental vitiligo/acrofacial vitiligo/mucosal vitiligo and vitiligo universalis
3.Participants with history of any other skin disorders and inflammatory condition of the skin
4.Pregnant or Lactating Women
5.Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction
6.Known cases of Diabetes Mellitus
7.Known cases of Immunocompromised states
|
|
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 |
Change In Vitiligo Area Scoring Index (VASI) |
0,2,4 and 8 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.Improvement in Patient’s Global Assessment (PGA) on VAS for Vitiligo
2.Improvement in Investigator’s Global Assessment (IGA) for Vitiligo
3.Improvement in QoL on VIS-22
(Assessment of Patient’s Quality of Life)
|
0 and 8 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)
|
01/05/2025 |
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="8" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
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
|
Baras (Vitiligo) is a skin
disorder caused by the destruction of melanocytes, leading to depigmented
patches. It affects 1%–2% of the global population and 3%–4% in India.
Conventional treatments, such as medications or surgical procedures, often have
limited effectiveness, side effects, and high costs. Unani medicine offers
accessible and cost-effective alternatives. Dimad-e-Baras a polyherbal Unani
formulation, is proposed to stimulate regimentation in vitiligo patients. A
clinical trial is planned to scientifically evaluate its safety and efficacy,
aiming to establish Dimad-e-Baras as a viable and affordable alternative to
conventional vitiligo therapies. |