| CTRI Number |
CTRI/2025/11/097946 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| 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
|
A Clinical Study To Evaluate The Safety And Efficacy Of A Polyherbal Unani Formulation In The Management Of Baras(Vitiligo) |
|
Scientific Title of Study
|
A Randomized,Parallel Group,Open Label,Active Controlled Clinical Study To Evaluate The Safety And Efficacy Of A Polyherbal Unani Formulation Compared With Methoxsalen 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 AFREEN SADIQUE SHAIKH |
| Designation |
PG SCHOLAR |
| Affiliation |
National Research Institute Of Unani Medicine For Skin Disorders (NRIUMSD), Hyderabad |
| Address |
Department Of Moalajat (Medicine), National Research Institute Of Unani Medicine For Skin Disorders, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad-500038
Hyderabad
TELANGANA
500038
India |
| Phone |
8379905848 |
| Fax |
|
| Email |
afreenshaikh2692000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARZEENA JABEEN |
| Designation |
PRINCIPAL & PROFESSOR |
| Affiliation |
National Research Institute Of Unani Medicine For Skin Disorders (NRIUMSD), Hyderabad |
| Address |
Department Of Moalajat (Medicine), National Research Institute Of Unani Medicine For Skin Disorders, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad-500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9032519286 |
| Fax |
|
| Email |
aarzu763@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AFREEN SADIQUE SHAIKH |
| Designation |
PG SCHOLAR |
| Affiliation |
National Research Institute Of Unani Medicine For Skin Disorders (NRIUMSD), Hyderabad |
| Address |
Department Of Moalajat (Medicine), National Research Institute Of Unani Medicine For Skin Disorders, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad-500038
Hyderabad
TELANGANA
500038
India |
| Phone |
8379905848 |
| Fax |
|
| Email |
afreenshaikh2692000@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), Hyderabad |
|
|
Primary Sponsor
|
| Name |
National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), Hyderabad |
| Address |
National Research Institute of Unani Medicine for Skin Disorders, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad-500038 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CCRUM |
New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR AFREEN SADIQUE SHAIKH |
National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), Hyderabad |
OPD NO 9,Deprtment of Moalajat National Research Institute of Unani Medicine for Skin Disorders, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad-500038
Hyderabad
TELANGANA |
8379905848
afreenshaikh2692000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, NRIUMSD, Hyderabad, Telangana,500038 |
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 |
| Comparator Agent |
1.Oral Methoxsalen (Tablet 10 mg)2.Topical Methoxsalen (1% Solution) |
1.Tablet will be given once daily on alternate days in the dose of 20-40 mg orally with water after meals, 1-2 hours before exposure to sunlight. 2.patients will be advised to carefully apply Methoxsalen(1%) solution topically on vitiliginous lesions, 1-2 hours after oral dose of Methoxsalen in the morning followed by sun exposure. |
| Intervention |
Polyherbal Unani Formulation |
Polyherbal Unani Formulation (Containing Tukhm-i-Siras, Tukhm-i-Karafs, Babchi)
Dosage Form: Oil (Liquid),
Routes of Administration: Oral and Topical,
Dosage:
Oral: 0.5 ml twice daily,
Topical: Quantity sufficient as per the extent of lesions.
Instructions:
Oral: Participants will be advised to take 0.5 ml Ravghan, orally twice daily an hour after meals.
Topical: The same Ravghan will be applied as Tila topically on the affected site once daily in early morning followed by sun exposure.
Sun Exposure: The exposure time was adjusted according to the skin sensitivity of an individual permits for 2 to 5 minutes in the early hours in the morning.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants of any sex aged 18-60 years
2.Non-Segmental Vitiligo with Chronicity of 6 months to 3 years
3.Participants with less than 5 new lesions in the last 1 month
4.Participants with less than 15 lesions in the last 3 months
5.Participants who have not taken systemic treatment within 4 weeks prior to study entry
6.Participants who have not taken topical treatment within 2 weeks prior to study entry
|
|
| ExclusionCriteria |
| Details |
1.Participants aged less than 18 years or more than 60 years
2.Segmental Vitiligo/ Lip-Tip vitiligo/ Universal Vitiligo/ vitiligo with Leucotrichia
3.History of photosensitivity/ photo exaggerated dermatoses and Connective Tissue Diseases
4.Pregnant or Lactating Women
5.Significant Cardiovascular/ Pulmonary/ Hepato-renal Dysfunction, or any chronic disease requiring long-term treatment
6.Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies (cutaneous or internal)
7.Participants not willing 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 |
| Reduction in Vitiligo Area Scoring Index (VASI) |
0,2,4,6, 8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Vitiligo Impact Scale (VIS)-22
(Assessment of Patient’s Quality of Life)
2.Improvement in Patient’s Global Assessment (PGA) on VAS
3.Improvement in Investigators Global Assessment (IGA) |
0 and 8th week |
|
|
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 |
|
Date of First Enrollment (India)
|
29/11/2025 |
| 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="6"
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 an acquired pigmentary disorder marked
by asymptomatic depigmented patches due to melanocyte loss. It affects 0.5–2%
of the population, with onset often before age 20, equally in both sexes. The
condition leads to psychological distress, low self-esteem, and impaired
quality of life. While several hypotheses—autoimmune, neural, and
biochemical—attempt to explain its pathogenesis, no single theory suffices.
Current treatments like psoralens and corticosteroids have limited efficacy
and notable side effects. Unani medicine offers safer, affordable alternatives.
Keeping in view the magnitude of
the problem a clinical study has been planned titled , A Randomized,
Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of
a Polyherbal Unani Formulation compared with Methoxsalen in the
Management of Baras (Vitiligo).
|
|