A Comparative Clinical Study on the Efficacy of JoshandaHaleela Siyah with Tila-e-Tukhm Turb and Tukhm Jarjir vsTukhm Kharpazah and Aard Baqla in Kalaf (Melasma)
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Reversal of mMASI, PGA, PtGA, scores
Study Overview
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 Tilaof 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 .
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 25.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
Reversal of mMASI, PGA, PtGA, scores
Time Frame: 28 days
Change in photographic lesion
Time Frame: 28 days
Secondary Outcomes
- NA(NA)