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A Clinical Study To Evaluate The Safety And Efficacy Of A Polyherbal Unani Formulation In The Management Of Baras(Vitiligo)

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) - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097946
Enrollment
60
Registered
2025-11-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L80- Vitiligo

Interventions

Intervention1: Polyherbal Unani Formulation: Polyherbal Unani Formulation (Containing Tukhm-i-Siras, Tukhm-i-Karafs, Babchi) Dosage Form: Oil (Liquid), Routes of Administration: Oral and Topical, Dosa

Sponsors

National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), Hyderabad
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Reduction in Vitiligo Area Scoring Index (VASI)Timepoint: 0,2,4,6, 8th week

Secondary

MeasureTime frame
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)Timepoint: 0 and 8th week

Countries

India

Contacts

Public ContactDR AFREEN SADIQUE SHAIKH

National Research Institute Of Unani Medicine For Skin Disorders (NRIUMSD), Hyderabad

aarzu763@gmail.com9032519286

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026