A Clinical Evaluation of Thulasi Ennai a Siddha Drug in the treatment of Soolikanam (Childhood Asthma) in Children.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Efficacy of the trail drug is measured by Peak Expiratory Flow Meter
研究概览
简要总结
Itis a single, non-randomized, open-label trial to determine the efficacy andsafety of THULASI ENNAI (Prepared from herbal constitutents) in patientswith SOOLI KANAM (CHILDHOOD ASTHMA). In this trial 40 patients willbe recruited and the trial drug will be administered orally twice a dayfor a period of 40 days. During this trial period all the study relateddata will be recorded and documented in a page separate trial master filefor each patients.During the trial period if any AE/SAE/SUSAR will be noticedand referred to pharmacovigilance dept in NIS and further management willalso be given in NIS OPD/IPD.The entire trial will be monitored by theresearch monitoring committee of NIS. During this trial allthe safety and efficacy parameters will be recorded in the CRF. Aftercompletion of the trial all the study related data will be analysedstatistically. The outcome of this trial will be published inIndian 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
- 7.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age : 7 – 12 years 2.Cough 3.Wheezing 4.Tightness of chest 5.Shortness of breath 6.Abdominal bloating 7.Loss of appetite.
排除标准
- •1.Children below 7 years and above 12 years 2.Haemoptysis 3.Pneumonia 4.Congenital heart disease 5.Status Asthmaticus.
结局指标
主要结局
Efficacy of the trail drug is measured by Peak Expiratory Flow Meter
时间窗: Before treatment (0th day) and After treatment (40th day)
次要结局
- Secondary outcome is assessed by comparing the following parameters before and after the treatment(1.Improve clinical symptoms)