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Evaluating efficacy and Safety of a topical Unani Formulation in the treatment of Kalaf(Melasma)

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

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/081866
Enrollment
60
Registered
2025-03-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: L814- Other melanin hyperpigmentation

Interventions

Intervention1: Topical Unani Formulation: Dosage form-: Qurs (tablet) for topical application Mode of Administration: Qurs will be crushed and Zimad (paste) for topical application will be prepared by

Sponsors

National Research Institute of Unani Medicine for Skin Disorders
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The following patients will be included in the study Participants of any gender in the age group of 18-60 years Participants having bilateral symmetrical or asymmetrical brown macules on face Participants who are willing to participate and comply with the protocol and to sign IEC approved ICF

Exclusion criteria

Exclusion criteria: Exclusion Criteria The following patients will be excluded from the study Participants aged less than 18 years and more than 60 years of age Pregnant or Lactating Women Mentally retarded person Known allergy, sensitivity or intolerance to the study drug or any of its ingredients Known case of significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction, Malignancy, HIV infection, AIDS, Hypothyroidism, Diabetes Mellitus, etc Participants not willing to give consent and to attend treatment schedule regularly

Design outcomes

Primary

MeasureTime frame
Change in MASI Score from baseline after 4 weeks of treatment.Timepoint: 28 days

Secondary

MeasureTime frame
Change in Melasma Quality of Life (MELASQoL) Scale Score from baseline after 4 weeks of treatment. Assessment of Safety (Local & Systemic) Timepoint: 28 days

Countries

India

Contacts

Public ContactProf Qamar Uddin

National Research Institute of Unani Medicine for Skin Disorders

qamaruddindr@gmail.com8700027178

Outcome results

None listed

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