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临床试验/CTRI/2022/04/041617
CTRI/2022/04/041617尚未招募2 期

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)

National Institute of Unani Medicine1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年9月4日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
44
试验地点
1
主要终点
Reversal of mMASI, PGA, PtGA, scores

研究概览

简要总结

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 .

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
25.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Reversal of mMASI, PGA, PtGA, scores

时间窗: 28 days

Change in photographic lesion

时间窗: 28 days

次要结局

  • NA(NA)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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