clinical study to evaluate the safety and efficacy of Dimad e baras in baras (Vitiligo)

Phase 2/3

Not yet recruiting

Conditions: Vitiligo,

Registration Number: CTRI/2025/03/081572

Lead Sponsor: National Research Institute of Unani Medicine for Skin Disorders

Brief Summary: Baras(Vitiligo) is a skindisorder caused by the destruction of melanocytes, leading to depigmentedpatches. It affects 1%–2% of the global population and 3%–4% in India.Conventional treatments, such as medications or surgical procedures, often havelimited effectiveness, side effects, and high costs. Unani medicine offersaccessible and cost-effective alternatives. Dimad-e-Baras a polyherbal Unaniformulation, is proposed to stimulate regimentation in vitiligo patients. Aclinical trial is planned to scientifically evaluate its safety and efficacy,aiming to establish Dimad-e-Baras as a viable and affordable alternative toconventional vitiligo therapies*.*

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change In Vitiligo Area Scoring Index (VASI)	0,2,4 and 8 weeks

Secondary Outcome Measures

Name	Time	Method
1.Improvement in Patient’s Global Assessment (PGA) on VAS for Vitiligo	2.Improvement in Investigator’s Global Assessment (IGA) for Vitiligo

Trial Locations

Locations (1): National Research Institute of Unani Medicine for Skin Disorders
🇮🇳
Hyderabad, TELANGANA, India
National Research Institute of Unani Medicine for Skin Disorders
🇮🇳Hyderabad, TELANGANA, India
Dr Hina Kausar
Principal investigator
7972260177
hinakausarhd@gmail.com