Phase II Non-randomized open clinical evaluation of siddha medicine Suringiyathi Chooranam for the management of Azhal Thalainokkadu (Sinusitis)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary outcome is mainly assessed by reduction of clinical symptoms after 48 days and also assessed by Adelaide symptoms severity score
研究概览
简要总结
This is a single non randomised open clinical trial to study the safety and efficacy of Suringiyathi Chooranam. The trial drug is given 2gms twice a day for 48days. The clinical trial is conducted after conducting pre clinical toxicity study. The trial drug Suringiyathi Chooranam is mentioned in Anuboga vaithiya Deva Ragasiyam.During the trial all the study related date will be recorded and documented. After the completion of trial all the data will be analysed 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
- 16.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Rhinorrhoea Headache Pain and tenderness over para nasal sinus Recurrent sneezing Hyposmia or anosmia Nasal congestion.
排除标准
- •Pregnancy and lactation Vasomotor rhinitis Opthalmic headache Migraine Otitis media.
结局指标
主要结局
Primary outcome is mainly assessed by reduction of clinical symptoms after 48 days and also assessed by Adelaide symptoms severity score
时间窗: Primary outcome is mainly assessed by reduction of clinical symptoms after 48 days and also assessed by Adelaide symptoms severity score
次要结局
- Secondary outcome is mainly assessed by comparing the safety parameters before and after treatment(48days)