Clinical evaluation of Adathoda rasayanam for the management of soolikanam(childhood asthma)in children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Efficacy of the trial drug is measured by peak expiratory flow meter
研究概览
简要总结
It is single non randomized open-label trial to determine the efficacy of Adathoda rasayanam for the management of Soolikanam.In the trial 30 Childhood asthma patients will be recruited and the trial drug Adathoda rasayanam will be administrated orally after food thrice a day.During the study period all the study related data will be recorded and documented in seperate trial master file for each and every patients.During the trial period if the patient develop any adverse effect he/she will be immediately referred to the chairman,pharmaco-vigilance commitee,NIS.If it will be mild event,the patient will be treated in OPD-NIS.If the event will be reserve,the patient will be referred to nearby Government Hospital and will be take over the patient,until he/she will get recovery.The treatment will be provided with free of cost.The entire trial will be monitored by yhe research monitoring commitee of NIS.During this trial all the safety and efficacy parameters will be recorded in CRF.After completion of the trial all the study related data will be analysed statistically.The outcome of this trial willbe publishes in Indian Journal of Medical Research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 3.00 Year(s) 至 7.00 Year(s)（—）
- 性别
- All
入选标准
- •Cough,Wheezing,Tightness of chest,Shortness of breath,Abdominal bloating,Loss of appetite.
排除标准
- •Hemoptysis,Active primary complex,Congenital heart disease,Pneumonia,Status Asthmaticus,Any other serious illness.
结局指标
主要结局
Efficacy of the trial drug is measured by peak expiratory flow meter
时间窗: 28 days
次要结局
- Reduction in the recurrence of the disease and improvement in the quality of life of children,Improvement in clinical symptoms(3 months)