A Clinical Study to Evaluate the Safety and Efficacy of Joshanda(Decoction) of Aftimoon(Cuscuta Reflexa Roxb) and Topical Application of Qust(Saussurea Lappa Clarke) with Honey in the Management of Kalaf(Melasma).
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Reduction of the hyperpigmentation spots in Melasma.
研究概览
简要总结
Kalaf (Melasma) is a common, chronic, accquired pigmentary disorder characterized by symmetric reticulated hyper pigmentation with irregular margins on the sun exposed areas of the face and rarely on the upper chest and extremities. It oocurs in all races and and ethnic groups, but is more prevelant in women and those people with Fitzpatrick skin type IV-VI and also in Hispanics, Asians and Africans. It occurs in 60% of pregnant women and 30% of women on oral contraceptive pills. The prevalance of melasma is 1.5%-33.3% globally. The most commonly affected age group is between 30-55 years, but rarely it can occur during puberty and post menopausal period.
Kalaf is described in all classical Unani textbooks like Al-Qanoon, Kamil-us- Sanah, Al-Havi, Al-Moalijat-al-Buqratiya etc. It is caused due to morbid matters especially sauda(black bile) under th skin. Thus it is treared by Istefragh (Evacuation) of black bile for which oral drugs are given, and also topical application of Jali(Clensing), Qabiz(Astringent), Muhammir(Rubefacient) drugs are given to treat Melasma. In allopathic system of medicine different treatment modalities are used in treatment of Kalaf, like topical drugs eg Hydroquinone, Azelaic acid, Kojic acid, oral drugs eg, Tranexamic acid, Glutathione etc and many procedural therapies eg microneedling, chemical peeling etc. All these treatments have numerous side effects like redness, irritation, allergy,burns,headache,abdominal bloating etc. Topical therapy is often insufficient to clear melasma causing many side effects also high relapserates after discontinuation of the treatment. This disease even though has no impact on general health it is associated with social stigma and has negative impact on quality of life. Keeping in view the above factors the present study is designed.
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
- 15.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •The following patients will be included: 1.Clinically diagnosed patients of Kalaf.
- •2.Irrespective of all genders.
- •3.patients between the age of 15 to 50 years.
排除标准
- •The following patients will be excluded: 1.Patients with history of Cardiovascular,Endocrine, Renal and Liver Diseases.
- •2.Skin sensitivity by history and clinical examination.
- •3.Pregnancy, Lactation and patients on oral contraceptives.
- •4.Patients on Anticoagulants.
结局指标
主要结局
Reduction of the hyperpigmentation spots in Melasma.
时间窗: 60 days
次要结局
- Heamatological and biochemical evaluation for safety.(60 days)
