Evaluation of efficacy and safety of Unani formulation in the management of Kalf (Melasma): A Randomized Controlled Study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- 1.Melasma severity index
研究概览
简要总结
Melasma is a common skin disorder characterized by symmetrical brown patches on the face, especially on the cheeks, forehead, and upper lip. It affects both genders but is more prevalent in women of reproductive age with darker skin tones. The term melasma is derived from the Greek word melas meaning black. In Unani medicine, it is known as Kalf and is thought to be caused by the accumulation of melancholic blood beneath the skin.
While the exact cause of melasma is unclear, contributing factors include genetics, sun exposure, pregnancy, and use of oral contraceptives or photosensitizing drugs. Conventional treatments involve topical agents like hydroquinone and chemical procedures such as peels and lasers. However, these methods often produce inconsistent results and may cause side effects like skin irritation or pigmentation.
This study aims to scientifically evaluate a traditional Unani treatment Zimad made from powdered Alsi and sugarcane vinegar. Patients will be randomly divided into three groups Test Group A will use only Zimad Test Group B will use Zimad with microdermabrasion and the Control Group will use glycolic acid 6 percent cream. The goal is to assess the effectiveness and safety of Unani treatment as a cost effective and side effect free alternative for managing melasma.
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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of all sexes between 18-50 years Clinically diagnosed patient of Melasma Female of reproductive age group agree to use acceptable form of birth control during study (except IUCD and hormonal contraception) Patient willing to sign the informed consent and to complete the study.
排除标准
- •Pregnant and lactating females Females using OCP (oral contraceptive pills) IUCD and hormonal contraception Patient having other skin diseases like acne dermatitis urticaria dermatophytosis Patients who have a known history or clinically relevant allergy in particular to any component of study medication Having systemic disorders such as hepatic and renal insufficiency endocrine disorders malignant or premalignant lesions immunodeficiency diseases neurological and cardiac disorders Patient consuming alcohol or drug abuse Patient have taken topical or systemic treatment of melasma for last one month Patient receive any cosmetic procedure such as chemical peel laser ablation FRT or dermabrasion for last 3 months Not willing to sign informed consent.
结局指标
主要结局
1.Melasma severity index
时间窗: 1.on day 0, 21, 42 | 2.on day 0, 42 | 3.on day 0, 42
2.Photography
时间窗: 1.on day 0, 21, 42 | 2.on day 0, 42 | 3.on day 0, 42
3.Safety evaluation
时间窗: 1.on day 0, 21, 42 | 2.on day 0, 42 | 3.on day 0, 42
次要结局
- MELASQOL (Melasma Quality of Life Scale)(on Day 0, 42)
研究者
Yougshi Ilahi
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital