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Clinical study to evaluate the efficacy and safety of a unani formulation in Kalaf (Melasma).

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

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050201
Enrollment
60
Registered
2023-03-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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: Herbomineral Unani Formulation: Dosage Form: Tila (Liniment) Dose: Quantity Sufficient Mode of Administration: Local Application. Composition: 1. Turmus(Lupinus albus Linn) 2. Tukhme

Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: Participant having single or multiple, irregular or regular, light to dark brown macules on the face (cheeks, nose, forehead, upper lip and chin). Chronicity of disease should be more than 4 months.

Exclusion criteria

Exclusion criteria: women who are pregnant and lactating. Participant aged less than 18 years and more than 55 years. Significant cardiovascular / pulmonary / hepato-renal dysfunction. Known case of diabetes mellitus, HIV / AIDS and malignancy. Those unwilling to come for regular follow-up for the entire duration of the study.

Design outcomes

Primary

MeasureTime frame
27% reduction in MASI score from baseline after 8 weeks of treatment.Timepoint: 8 weeks

Secondary

MeasureTime frame
Systemic safety assessmentTimepoint: 8 weeks

Countries

India

Contacts

Public ContactDr Sheikh Ayesha Aijaz

National Research Institute of Unani Medicine for Skin Disorders.

ccrumnawab@gmail.com08100992044

Outcome results

None listed

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