Clinical evaluation of the effect on oral administration of ELATHI CHOORANAM along with external administration of KAIYANTHAGARAI TAILAM in the management of VADHAPEENISAM.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Decreases the frequency of sneezing, prolonged running nose, nasal congestion and other clinical symptpoms.
研究概览
简要总结
It is a single arm clinical trial to determine the safety and efficacy of ELATHI CHOORANAM(oral administration) along with KAIYANTHAGARAI TAILAM (external administration) in patients with VADHAPEENISAM. The outcome will measured by day 1,week 1 week 2, week 3 intervals.During this period if any adverse effect and serious adverse effect will be noticed and referred to pharmacovigilance department in Government siddha medical college and hospital, Palayamkottai and for the management will also be given in department of Kuzhanthai maruthuvam OPD and IPD. After the completion of trial all the study related data will be analyzed statistically.
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
- 7.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with any of the following symptoms will be included in the study 1.Pain and swelling of the maxillary region 2.Frequent Sneezing with seasonal allergy 3.Frequent focusing for allergy 4.Prolonged running nose(Rhinitis).
排除标准
- •1.Children below 7 years and above 12 years 2.Severe and recurrent epistaxis due to rhinitis 3.Rhinisporidiasis 4.TB rhinitis 5.Severe form of DNS(Deviated Nasal Septum).
结局指标
主要结局
Decreases the frequency of sneezing, prolonged running nose, nasal congestion and other clinical symptpoms.
时间窗: 21 days
次要结局
未报告次要终点