Comparative study of Drug Utilization and effects in Ayurveda and Conventional treatment in Bronchial Asthma.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- NA
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Drug utilization patterns and effects of treatment in patients with Bronchial Asthma will be assessed.
研究概览
简要总结
This is a prospective observational study which compares theDrug Utilization patterns and effects in Ayurveda and Conventional treatment inpatients with Bronchial Asthma which will be conducted in India in KasturbaHospital, Manipal in a minimum of 250 patients for the approved duration ofstudy. The primary objective of this study is to study the Drug Utilization patternsand effects of therapy in Ayurveda and Conventional treatment in patients withBronchial Asthma and the secondary objective of this study is to study theQuality of Life among Bronchial Asthma patients along with assessment of directcost of therapy per patient. The drug utilization patterns will be comparedamong patients of out-patient department in Ayurveda and Respiratory medicine separately.The information obtained will be noted in a suitable designed CRF. Follow-upwill be done on the visit or by contacting the patient. The Quality of lifewill be measured using Asthma Quality of Life Questionnaire (AQLQ), astandardized widely available and validated instrument to assess quality oflife in Asthmatic patients. Efficacy will be assessed according to the domainsin the Quality of Life Questionnaire. As a routine investigation, the directcost burden will be compared between both the therapies and will also becalculated for every patient. The confidentiality of the patient data collectedwill be duly respected and the name of the patient will not be noted under anycircumstance.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Out patients visiting the Respiratory and Ayurveda departments.
排除标准
- •Patients with cardiovascular disease (Cardiac arrest, Arrhythmia, Congenital Heart Disease, Stroke).
- •Patients with hepatic and renal impairment.
- •Pregnant and lactating women.
- •Patients with neurological impairment.
结局指标
主要结局
Drug utilization patterns and effects of treatment in patients with Bronchial Asthma will be assessed.
时间窗: Data will be collected for 12 months which will be followed by organizing and analysis of the data collected for 2 months and then 1 month will be used to prepare a report.
次要结局
- Quality of life of patients will be assessed along with the direct cost of therapy per patient.(Data will be collected for 12 months which will be followed by organizing and analysis of the data collected for 2 months and then 1 month will be used to prepare a report.)