CTRI/2025/03/081866尚未招募2/3 期
A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to Evaluate the Safety and Efficacy of a topical Unani Formulation in the treatment of Kalaf (Melasma)
National Research Institute of Unani Medicine for Skin Disorders1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月2日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in MASI Score from baseline after 4 weeks of treatment.
研究概览
简要总结
| Melasma (Greek: “a black spot”) is an acquired lighter dark-brown hyperpigmentation on face. It presents 0.25 to 4% of dermatology clinic patients in Southeast Asia. Females are more affected than males. Melasma has been treated with modern topical medicines such Hydroquinone, Tretinoin, Tranexamic Acid, Azelaic acid and Triple Combination Cream but the negative side effects, including skin irritation, rashes and allergy are possible. In Unani system of medicine,various topical single medications and compound formulations, are available. Keeping in view all above facts, a topical Unani formulation comprising Katira, Booraq with Sirka has been selected from Al-Qanun fi Tibb, and the present study has been designed. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •The following patients will be included in the study Participants of any gender in the age group of 18-60 years Participants having bilateral symmetrical or asymmetrical brown macules on face Participants who are willing to participate and comply with the protocol and to sign IEC approved ICF.
排除标准
- •The following patients will be excluded from the study Participants aged less than 18 years and more than 60 years of age Pregnant or Lactating Women Mentally retarded person Known allergy, sensitivity or intolerance to the study drug or any of its ingredients Known case of significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction, Malignancy, HIV infection, AIDS, Hypothyroidism, Diabetes Mellitus, etc Participants not willing to give consent and to attend treatment schedule regularly.
结局指标
主要结局
Change in MASI Score from baseline after 4 weeks of treatment.
时间窗: 28 days
次要结局
- Change in Melasma Quality of Life (MELASQoL) Scale Score from baseline after 4 weeks of treatment.(Assessment of Safety (Local & Systemic))
研究者
Dr Nameera Zehra
National Research Institute of Unani Medicine for Skin Disorders
研究点 (1)
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