Evaluation of the efficacy and safety of topical application of Tukhm-e-Turb and Tukhm-e-Jarjir in the management of Kalf (Melasma)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- • modified Melasma Area Severity Index (mMASI)
研究概览
简要总结
Kalf (Melasma) is an acquired hyper melanotic condition that generally strikes women and is characterized by symmetrical light brown to grey brown macules or patches that form over the cheeks, around the eyes, at chin and across the forehead. As classified according to the location of the pigment, three types of melasma exist, namely, epidermal, dermal, and mixed. According to Unani system of medicine, Kalf commonly called as Jhae’en which develops by burnt blood that leaks from capillaries and pools up underneath the skin .
Despite the fact that melasma can affect people of all sexes and skin types, it is most prevalent among adult women with darker skin tones aged between 27 and 57 years. The prevalence of melasma is 1% in the general population and as high as 50% in high-risk populations. It varies from 0.25% to 4% in Southeast Asia. It is the most typical hyper pigmentary disorder among Indians, and the female-to-male ratio is around 4:1.
Due to the fact that melasma mostly affects the face, which causes patients to feel distressed, it has a negative impact on the patients’ quality of life, hurting their psychological and emotional well-being as well as social interactions. Sometimes this might lead the patient to feel shame, frustration, embarrassment, low self-esteem, and demotivation.
Regardless of the numerous treatment options available to treat melasma, it remains a medical concern. As it is recalcitrant to available treatments.
Kalf (Melasma) is treated in the Unani system of medicine with time-tested formulations that possess properties like Muṣaffῑ-i-Dam, Ghassᾱl, Moḥallil, Jᾱlῑ, and Mohassin e Lawn, which are quite effective and have no or fewer adverse effects. Therefore, there is a need to validate the Unani treatment on contemporary, scientifically validated, and reliable parameters. In addition to this, it is cost-effective, economical, and, by far, accessible and safe to use
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 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Clinically diagnosed patients of Kalf (Melasma) by wood’s lamp examination.
- •2 Patients with Fitzpatrick skin types III, IV and V 3 Patients of all sexes.
- •4 Patients who are willing to sign the written consent form prior to participation in the study.
排除标准
- •1 Pregnant and lactating women.
- •2 Patients having used any cosmetic depigmenting agent within 2 weeks prior to inclusion in the study.
- •3 Female on oral contraceptives and hormone therapy at the time of study.
- •4 Patients having used topical or systemic corticosteroid within 1 month prior to inclusion in the study.
- •5 Patients having history of laser treatment or dermabrasion or deep facial peels within the past 3 months.
- •7 Patients who have a known history of renal insufficiency, severe liver or heart diseases, neurological disorders, malignancy, HIV infection, AIDS, etc.
- •8 Patients unlikely to comply with the study protocol.
结局指标
主要结局
• modified Melasma Area Severity Index (mMASI)
时间窗: Baseline,2nd week, 4th week and 6th week
• Patient Global
时间窗: Baseline,2nd week, 4th week and 6th week
Assessment (PtGA)
时间窗: Baseline,2nd week, 4th week and 6th week
次要结局
- Melasma quality of life scale (MELASQoL)(Baseline and 6th week)
研究者
Faiza Hussain
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital