CTRI/2024/06/068821尚未招募2 期
A Single-blind Standard Controlled Randomized clinical trial of Unani formulation in the management of Kalaf (Melasma).
DEPARTMENT OF AMRAZ E JILD WA ZOHRAWIYA1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年7月15日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Modified Melasma Area and Severity Index score (mMASI score).
研究概览
简要总结
The objective of the study is to evaluate the efficacy and safety of Rewand Chini (Rheum emodi) in paste form for local application in the management of Kalaf*(Melasma)*
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Age- 18 years and above.
- •Both male and female patients.
- •All skin types (Fitzpatrick I to VI).
- •Patients who signed the written consent form.
- •Epidermal and mixed pattern of melasma.
排除标准
- •Patients below 18 years.
- •Patient with systemic disease eg: DM, Malignancy, Thyroid dysfunction, CKD, and TB (as per history and clinical examination).
- •History of hypersensitivity reaction to drugs.
- •Patients who were not willing to sign the consent form or remain absent during the study.
- •Pregnant and Lactating mothers.
- •Women who are on OCPs (progesterone).
结局指标
主要结局
Modified Melasma Area and Severity Index score (mMASI score).
时间窗: 15th, 30th, 45th day
Melasma Quality of Life scale (MelasQoL)
时间窗: 15th, 30th, 45th day
Photographs (without using filters)
时间窗: 15th, 30th, 45th day
次要结局
- Fairness, Glow, and Shining(15th, 30th, 45th day)
研究者
Safiya Naiyar
Ajmal Khan Tibbia College
研究点 (1)
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