Efficacy of Rewandchini with Asl as Zimad in Kalaf (Melasma) - A Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- improvement in kalaf melasma as per mMASI score and PGA score
研究概览
简要总结
Melasma is common hypermelanosis that typically occurs on sun-exposedareas in the face. The overall prevalence of Melasma in women varies bygeography and population between 1.5% and 33.3%. The estimated prevalenceof melasma in pregnant women is up to 70%. The prevalence of melasma in men assuggested in one simple survey is approximately 20%. It is a cosmeticissue that sometimes cause great psychological suffering. As per one study,which showed that melasma associated with significant impact on health-relatedquality of life. It is characterized by sharply demarcated, blotchy, brownmaculae, usually symmetrical on the cheeks, forehead, sometimes on the upperlip and neck. According to Unani system factors affecting kalaf includesfrequent exposure to excess abnormal external heat; Dam-e-Muharraq (charredblood), Sauda-e-Muharraq (charred melancholic blood), Ghiza-e-Kaseef (indigestiblefood), constant local pressure, pregnancy, liver disease i.e. Du’fal-kabid (liver atony) and Sughà r al-kabid. Although Melasma isasymptomatic it is disfiguring skin disease that has a negative impact on lifeand the self-esteem of effected individuals and causes distress in the patientsas it mainly affects the face. It affects their psychological andemotional wellbeing and often feel bothered, frustrated, embarrassed, anddepressed about their skin appearance.
The physician described various regimenal and pharmacotherapies for themanagement of Melasma in detail. The Pharmacological action of zimad inpresent study exhibits: Jali (detergent), qabiz (astringent), Qasir (Scaling), Ghassal (irrigator), Mubassir (vesicant), Muhammir (rubifecient), Raade-Mawaad (divergent), Mughazzi (nutrient), muhalil-e-awram (anti-inflammatory),antioxidant, antimicrobial, dafa-e-quba (antifungal), mana-e-sartan (anticancer), mana-e-qurooh (antiulcer)properties.
Therefore a clinical trial entitled ’Efficacy of Rewandchini with Asl as Zimad in Kalaf (Melasma)- A Randomized controlled trial’ is contemplated to evaluate the efficacyof rewandchini with Asl with the objective of improvement in skin lesions andto improve the quality of life of the sufferers of Melasma.
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
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •1 Clinical patients of Kalaf (Melasma) 2 Patients of either sex 3 Patients between 18-50yrs of age 4 Patients with Fitzpatrick skin type III- type V 5 Patient m-MASI score up to 3 (Moderate/Marked) in darkness and ≤ 49% in Area 6 Duration of Melasma ≤ 3yrs 7 Willingness to participate in the study and follow the instructions.
排除标准
- •1 Patients with any systemic illness and malignancies 2 Patients on contraceptive pills 3 Skin sensitivity 4 Severe cases of Melasma (m-MASI score >50%) 5 Pregnancy/ Lactating women 6 Hormonal replacement therapy 7 Topical bleaching agents for at least 1month or chemical peeling or laser at least 4months before the start of the study.
结局指标
主要结局
improvement in kalaf melasma as per mMASI score and PGA score
时间窗: improvement in kalaf melasma as per mMASI score and PGA score on 7th 14th 21st 28th 35th 42nd day
次要结局
未报告次要终点
