Preclinical and Clinical evaluation of karappan nei (internal and external medicine) in the treatment of Bala karappan (Eczema) in children on open clinical study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- It is mainly assessed by reduction of Clinical symptoms by using SCORAD scale
研究概览
简要总结
It is the single non-randomized,open label trial to determine the efficacy of Karppan nei (internal and external medicine) prepared from herbal constitutents in the patients with Balakarappan (Eczema). In this trial 30 patients will be recruited and the trial drug will be administered 5-10 ml Twice a day with honey for a period of 48 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
- •Children with symptoms of pain in lower extremities, Itching, Papules, Vesicles, Pustules, Ulcer, Oozing, Hyper pigmentation, Sleep disturbances 2.Patients willing to Blood investigation when required
- •Patient willing to be admitted in the hospital or willing to attend OPD once in 7 days for 48 days.
排除标准
- •1.Scabies
- •Photo dermatitis
- •patients with any other serious illness.
结局指标
主要结局
It is mainly assessed by reduction of Clinical symptoms by using SCORAD scale
时间窗: 48 datys
次要结局
- It is mainly assessed by therapeutic efficacy of the trial drugs(48 days)