Clinical evaluation of siddha drug Seenthil choornam(internal) and Puzhuvettu thylam(external) in the treatment of Puzhuvettu (alopecia areata) in children on open clinical study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Primary outcome is mainly assessed by severity of Alopecia tool score(SALT SCORE)
研究概览
简要总结
It is the single non-randomized,open label trial to determine the efficacy of Seenthil choornam (internal) and Puzhuvettu thylam (external) prepared from herbal constitutents in the patients with Puzhuvettu (Alopecia areata). In this trial 10 patients will be recruited and the trial drug will be administered 350mg - 700mg Twice a day with sugar for a period of 45 days. During the trial period if any AE/SAE/SUSAR will be noticed and refered to pharmacovigilance department in NIS and further management will also be given in NIS OPD/IPD. The entire trial will be monitored by the research monitoring committee of NIS. During this trial all the safety efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically. The outcome of this trial will be published in India Journal of Medical research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Scattered long hair within the bald area 2)Unscarring 3)The area of hair loss may tingle or be painful 4)Affecting region is small 5)Hair loss present on the patches 6)Patients who are satisfying minimum of 3-4 above mentioned symptoms 7)Patient willing to undergo routine blood investigation.
排除标准
- •Loss of hair in the shape of a way at the circumference of the head 2) Scarring alopecia 3)In case of severe hair loss 4) Alopecia tottalis 5) Vitiligo 6)Atopic dermatitis 7) Thyroid disease 8)Down syndrome.
结局指标
主要结局
Primary outcome is mainly assessed by severity of Alopecia tool score(SALT SCORE)
时间窗: 45 days
次要结局
- Secondary outcome is assessed by comparing the following parameters before and after the treatment(1) Improvement in clinical symptoms)