A single arm clinical study to evaluate the efficacy of an ayurvedic formulation in the management of tamak shwasa. (Bronchial Asthma).
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in the symptoms of tamak shwasa(Bronchial Asthma) and improvement in the peak expiratory flow rate.
研究概览
简要总结
To study the efficacy of an ayurvedic formulation in management of tamak shwasa (bronchial asthama).
There are total 30 patients, ayurvedic formulation of 500 mg two tablets will be given with luke warm water before food in morning and evening, the study will be of 28 days and follow up on 14th and 28th day.
Peak expiratory flow rate, breath holding time, CBC with ESR, SpO2 saturation, LFT, RFT will be tested before and after and final conclusion will be drawn on the basis of statistical methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •The patient having a classical features of Tamak shwasa (Bronchial asthma) like Frequency of shwasa vega (Shortness of breath) Kasa (Cough), Pinasa (Coryza), Ghurghurukam(Wheezing) Asino labhyate soukhyam(Relieves discomfort insitting), Anidra (Disturbed sleep).
- •Age between 18 to 70 years.
- •History of Tamak shwasa less than 5 year Peak flow meter rate more than 80lit/m and less than 300lit/m.
- •Class-All socio-economic classes.
排除标准
- •Patients with a history of Tamak Shwasa (Bronchial Asthma) more than 5 yrs.
- •Asthma due to other systemic disorders, and Tuberculosis Lung cancer, Cystic Fibrosis,Pneumonia, Pleural effusion, and other respiratory disorder.
- •Asthma in pregnant women.
- •Patient in status asthmaticus.
结局指标
主要结局
Reduction in the symptoms of tamak shwasa(Bronchial Asthma) and improvement in the peak expiratory flow rate.
时间窗: 28 days with follow up on 14th , 28th day
次要结局
- To assess the improvement in peak expiratory flow rate, breath holding time, respiratory rate(28 days with follow up on 14th , 28th day)
研究者
Dr Harshit Kalkhundia
Dr D Y Patil college of ayurveda and research centre
