Clinical Study for Comparative Evaluation of a Unani Formulation in the Management of Huzaz (Dandruff)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- sign and symptoms
研究概览
简要总结
Proposed open label, randomized, comparative, controlled study and will be carried out in 90 patients of diagnosed cases of Huzaz (dandruff ). Total 90 patients to be randomly allocated to Group A, Group B and Control Group C with 30 in each group. A group-Zulamla formulation, B group-Zulamla in Shampoo base,C group-Ketoconazole Shampoo 1%. Each group will be assessed on 0th,14th and 28th day(end of trial) using various outcome measures including Total Dandruff score scale, Scalpdex questionnaire, Sebumetery, Scalp scrapping for 10% KOH Staining. Safety will be assessed using Clinical and Hematological parameters including CBC, KFT, LFT.The proposed study will provide effective and easily usable treatment of dandruff with least side effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically Diagnosed cases of Huzaz(dandruff) Provided written informed consent willing to participate in complete test process Patient using any other medication for dandruff will be included after washed out period of one week.
排除标准
- •Patient who fail to give consent Patient who has any hair related disorder such as, Tinea capitis, contact dermatitis, alopecia areata and psoriasis No hair perming or coloring in the last two months and promised no hair perming or coloring during the study period.
结局指标
主要结局
sign and symptoms
时间窗: 0 day,14th day,28th day
total dandruff score scale
时间窗: 0 day,14th day,28th day
Scalpdex questionairre
时间窗: 0 day,14th day,28th day
次要结局
- scalp scrapping of 10% KOH staining,sebumetery(0 day,28th day)