Efficacy of Unani drugs on Melasma

Phase 2

Not yet recruiting

• Conditions: Other melanin hyperpigmentation,

• Registration Number: CTRI/2022/04/041617
• Lead Sponsor: National Institute of Unani Medicine

Brief Summary

Diagnosed cases of Melasma fulfilling the inclusion criteriawill be enrolled into clinical trial after obtainingwritten informed consent, then they will be randomly allocated into two groupseach 23; viz Group A will receivelocal application of *Tila* of *Tukhme Turb* and *Tukhme Jarjir and* Group B *Tila*of *Aad Baqla* and *Tukhmekharpazah,* both groups will be given Joshanda Haleela Siyah orally alongwith hot water vapors fomentation.Assessment of outcome will be carried out with m-MASI Score and pGA Scale, photography of the lesions and Dermoscopy on 0 (baseline) 7th , 14th and on 21th day of the trial followed by Post trial follow u will made on 28th day to findout any residual effect of the therapy. Drugsafety will be ensured by monitoring the haematological and serologicalindicators. Efficacy analysis will be performed on Intention-to-treat (ITT)basis using the last observation carry forward method(LOCF) on participants those received all the dosesof both test and comparator drugs and underwent at least two assessment post baseline. The study data will be analyze statistically with appropriate test. Pvalues of last than 0.05 will be considered statistically significant .

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-03-30
• Study Start: 2022-09-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Patients with Fitzpatrick Skin phototype 3rd to 6th Patients m MASI Score up to Marked in Darkness (0-3) and ≤ 49 % in Area Duration of Melasma ≤ 3 Yrs.
• Patient willing for study.

Exclusion Criteria

• Pregnant and Lactating women Patients with systemic disease e.g. Malignancy, Thyroid Dysfunction, CKD, Tuberculosis.
• History of any Skin therapies related to Hyperpigmentation History of Hypersensitivity Reaction with Drugs.
• Severe Cases of Melasma.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in photographic lesion	28 days
Reversal of mMASI, PGA, PtGA, scores	28 days

Secondary Outcome Measures

Name	Time	Method
NA	NA

Trial Locations

Locations (1)

Room No. 4 Skin OPD National Institute of Unani Medicine; 🇮🇳 Bangalore, KARNATAKA, India

Room No. 4 Skin OPD National Institute of Unani Medicine

🇮🇳Bangalore, KARNATAKA, India

Dr Tuba Hanif Zulfar

Principal investigator

9987159752

tubazulfar786@gmail.com