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Clinical study on 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) - NA

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/066027
Enrollment
60
Registered
2024-04-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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 (homogenous powder as paste in water): Composition: Siyah Mirch (Piper nigrum) and Booraq (Borax) Dose: As per required at bedtime Mode of Administration: Topi

Sponsors

NATIONAL RESEARCH INSTITUTE OF UNANI MEDICINE FOR SKIN DISORDERS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Participants of any gender in the age group of 18-60 years. Participants having bilateral symmetrical or asymmetrical brown macules on face (nose, forehead, upper lip and cheeks & chin ). Participants who are willing to participate and comply with the protocol and to sign IEC approved ICF.

Exclusion criteria

Exclusion criteria: The following participants will be excluded from the study: Participants aged less than 18 and more than 60 years. 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 follow-up for the entire duration of the study and any patient considered not eligible in the investigator’s discretion.

Design outcomes

Primary

MeasureTime frame
25 % reduction in MASI Score from baselineTimepoint: At baseline 2nd, 4th, 6th and on 8th Weeks

Secondary

MeasureTime frame
Melasma Quality of LifeTimepoint: At baseline and on 8th Week

Countries

India

Contacts

Public ContactDR KHIZER HABEEB

NATIONAL RESEARCH INSTITUTE OF UNANI MEDICINE FOR SKIN DISORDERS

drmdhussainshaikh143@gmail.com7989789310

Outcome results

None listed

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