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 (5 Percent) in the Management of Buthur 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
- Primary Outcome Measures
研究概览
简要总结
Buthur Labaniyya (Acne vulgaris) is a common disorder of the pilosebaceous unit affecting adolescents, often leading to scarring and psychosocial impact. Conventional drugs provide relief but have adverse effects and high recurrence. Unani medicine describes effective formulations with Jali(detergent), Muhallil (resolvent), and Mujaffif (desiccative) properties. Haldi(Curcuma longa) and Kaf-i-Darya (cuttlefish bone) are traditionally used for their anti-inflammatory, antiseptic, and blood-purifying actions. This clinical study aims to scientifically evaluate the safety and efficacy of a topical Unani formulation versus Benzoyl Peroxide in acne management, generating evidence-based support for Unani interventions in dermatological care.
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
- 14.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •The following Participants will be included in the study: a) Participants of any sex in the age group between 14 and 40Years b)Clinically stable patients c) Participants having the following signs & symptoms of Buthur Labaniyya: Comedones Papules Pustules Nodules Itching Erythema.
排除标准
- •The following Participants will be excluded from the study: a)Participants aged Less then 14 years or More then 40 years b)Pregnant or Lactating Women c) Mentally retarded person d)Patients on corticosteroid or anticonvulsant therapy or taking oral contraceptives e)Patients suffering from other concomitant diseases, like acne rosacea, acne fulminans, acne necrotica, psoriasis, eczema,etc.
- •f)Significant Pulmonary,Cardiovascular,Hepato-renal Dysfunction.
- •g)Patient not willing to attend treatment schedules regularly.
结局指标
主要结局
Primary Outcome Measures
时间窗: Participants will be followed-up for evaluation at 2, 4, & 6 weeks
1. Change in Global Acne Grading System (GAGS) Score from baseline to 6 weeks of treatment
时间窗: Participants will be followed-up for evaluation at 2, 4, & 6 weeks
2. Change in Cook’s Acne Grading Scale (CAGS) Score from
时间窗: Participants will be followed-up for evaluation at 2, 4, & 6 weeks
baseline to 6 weeks of treatment
时间窗: Participants will be followed-up for evaluation at 2, 4, & 6 weeks
3. Change in Patient’s Global Assessment (PGA) on VAS from baseline to end of 6 weeks
时间窗: Participants will be followed-up for evaluation at 2, 4, & 6 weeks
4. Change in Period of Clinical Recovery from baseline to week 6
时间窗: Participants will be followed-up for evaluation at 2, 4, & 6 weeks
次要结局
- 1.Evaluation of Safety by:(a.Monitoring Adverse Events (AEs):)
研究者
Dr Shaikh Nazia Rashid Ahmed
National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), Hyderabad