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A study in adults testing a Unani topical formulation to evaluate its safety and effectiveness in reducing melasma

A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of a Topical Unani Formulation in the Management of Kalaf (Melasma) - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098763
Enrollment
60
Registered
2025-12-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: L811- Chloasma

Interventions

Intervention1: Topical Unani Formulation (Tila): Topical Unani Formulation (Tila) Dosage Form : Tila (liniment) Dose : The participants will be advised to apply the prepared Tila on the affected site

Sponsors

Government Nizamia Tibbi College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Participants having single or multiple, symmetrical or asymmetrical brown macules on face (cheeks, nose, forehead, upper lip and chin) Chronicity more than 4 months

Exclusion criteria

Exclusion criteria: Pregnant and lactating women,Known cases of significant Pulmonary ,Cardiovascular,Hepato-renal Dysfunction,Malignancy, Endocrine disorders, HIV infection, AIDS, etc.,Known allergy,sensitivity or intolerance to the study drug or any of its ingredients,Participants with active alcohol intake and/or drug abuse,Those unwillingly to come for regular followup for the entire duration of the study and any patient considered not eligible in the investigator s discretion.

Design outcomes

Primary

MeasureTime frame
Change in Mean MASI Score from baseline to 2nd, 4th, and 6th week post treatmentTimepoint: Change in Mean MASI Score from baseline to 2nd, 4th, and 6th week post treatment

Secondary

MeasureTime frame
Changes in Melasma Quality of Life assessment will be done at baseline & 6th week post treatmentTimepoint: Changes in Melasma Quality of Life assessment will be done at baseline & 6th week post treatment

Countries

India

Contacts

Public ContactDr Muzammil Mushtaq Hussain

Government Nizamia Tibbi College

ahmedfarhath66@gmail.com9848195067

Outcome results

None listed

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