A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of a topical Unani Formulation compared with Benzoyl Peroxide (2.5%) in the Management of Buthūr Labaniyya (Acne Vulgaris)
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
- Reduction in Global Acne Grading System (GAGS)
研究概览
简要总结
Acne is a chronic inflammatory disease of the pilosebaceous units, characterized by seborrhoea, formation of open and closed comedones, erythematous papules, pustules, nodules, deeppustules and pseudocysts. Acne, the eighth most prevalent disease globally, affects 9.4% of population.
Conventional treatments can cause skin irritation, burning, drying, itching and redness. In Unani medicine, many single and compound drugs are available for Buthūr Labaniyya, but many of them have not been evaluated clinically on scientific parameters.
Keeping this in view, the present study is designed to evaluate the safety and efficacy of A Topical Unani formulation in the management of Buthūr Labaniyya
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
- 15.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •The following patients will be included in the study:
- •Participants of either gender in the age group between 15 to 35 years
- •Participants having any of the following symptoms of ButhÅ«r Labaniyya like Comedones, Papules, Pustules ,Nodules, Itching, Erythema
- •Participants willing to give consent or assent and attend follow-up visits regularly 4.Clinically stable patients.
排除标准
- •The following patients will be excluded:
- •Patients aged less than 15 years or more than 35 years
- •Participants with other variants of acne like acne fulminans, acne rosacea, acne necrotica.
- •Patients on corticosteroid or anticonvulsant therapy or taking oral contraceptives
- •Pregnant or Lactating Women
- •Significant Pulmonary/ Cardiovascular/ Hepato-renal Dysfunction and other Disorders requiring long-term treatment
- •Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies ï‚· Patient not willing to attend treatment schedule regularly.
结局指标
主要结局
Reduction in Global Acne Grading System (GAGS)
时间窗: 0,2 and 4 weeks
次要结局
- 1. Patient’s Global Assessment (PGA) on VAS(2. Dermatology Life Quality Index (DLQI) Scores)
研究者
DR NAILA NAAZ
National Research Institute of Unani Medicine For Skin Disorders