A Clinical Study to Evaluate the Efficacy and Safety of Tila-i Muhasa in the Management of Busur Labaniyya (Acne Vulgaris)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 3. Photographic Standards for Acne Grading (PSAG)
研究概览
简要总结
BusurLabaniyya (Acne vulgaris) is a folliculardisorder affecting susceptible pilosebaceous follicles, primarily of the face,neck, and upper trunk and characterized by both non-inflammatory andinflammatory lesions. It is one of the most common dermatoses affecting the teenagepopulation. Boys have a peak incidence between age of 16 and 19 years and girlsbetween age of 14 and 16 years. Both sexes are equally affected.
As per Unani classics, Acne Vulgaris is termed asBusurLabaniyya, Muhasa or Keel. BusurLabaniyya, which means eruptions of milk due to whitish dischargeresembling milk.
IbnSina (Avicenna) says in his famous book, Al-Qanun fi’l Tibb (Canonof Medicine) thatMuhasa are small white eruptions on the noseand cheeks which resemble condensed drop of milk.
The drugs used forthe treatment of Busur Labaniyya (Acne Vulgaris) inconventional medicine are effective, but pronged use of these drugs may produceside effects like burning, dry skin, erythema, peeling, etc., and recurrence rateis also high.
In Unani Medicine*, Busur Labaniyya* (Acne Vulgaris) is a wellrecognized disease entity and has been treated successfully since antiquitywith various single and compound drugs having Jali (Detergent), Muhalil (Resolvent)and Mujaffif (Desiccative) properties, but data regardingtheir efficacy and safety are not available.
Keeping this in view, it has been planned to conduct a clinicaltrial entitled "A Clinical Study to Evaluate the Efficacy and Safetyof Tila-i Muhasa in the Management of Busur Labaniyya (AcneVulgaris)".
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Open Label
入排标准
- 年龄范围
- 14.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •i)Patients of any sex in the age group between 14 and 40 years ii) Clinically stable patients iii) Patients having the following symptoms of Busur Labaniyya:
- •Comedones
- •Pustules 4.
排除标准
- •Patients aged <14 years or >40 years
- •Pregnant or Lactating Women
- •Mentally retarded person
- •Patients on corticosteroid or anticonvulsant therapy or taking oral contraceptives
- •Patients suffering from other concomitant diseases like acne rosacea, acne fulminance, acne necrotica, psoriasis, eczema, etc.
- •Significant Pulmonary/Cardiovascular/Hepato-renal dysfunction
- •Patient not willing to attend treatment schedule regularly.
结局指标
主要结局
3. Photographic Standards for Acne Grading (PSAG)
时间窗: at baseline 2wk 4wk and 6wk
2. Photographic Standards for Acne Grading (PSAG)
时间窗: at baseline 2wk 4wk and 6wk
The response to treatment will be assessed using the following parameters:
时间窗: at baseline 2wk 4wk and 6wk
1. Global Acne Grading System (GAGS)
时间窗: at baseline 2wk 4wk and 6wk
次要结局
- To compare the improvement in quality of life in patients with Acne Vulgaris assessed by PGA on VAS and IGA(at baseline 2wk 4wk and 6wk)