Effect of Reflexology, Homeopathy and Conventional Medical Treatment in Asthma: A Randomised Controlled, Parallel Group Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- The change in the Asthma Quality of Life Questionnaire(AQLQ)
研究概览
简要总结
There is a lack of scientific evidence that homeopathy and reflexology is effective treatment of asthma. Systematic reviews have found that many clinical trials testing homeopathy and reflexology have major flaws, such as small number of participants, lack of control groups or inadequate allocation concealment.
The aim of the present study was to assess the effect of reflexology and individualised homeopathy as an adjuvant treatment in asthma. In order to address this issue, the investigators conducted an investigator-blinded, randomized, controlled parallel group study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Forced expiratory volume in 1 second (FEV1) ≥60% predicted
- •A history of bronchial asthma for minimum 6 months prior to baseline
- •An objective measure of abnormal variation in bronchial calibre(The objective measure were defined as at least one of the following)
- •a positive bronchodilator reversibility test, defined as increase in FEV1≥10% after 400 µg inhaled salbutamol;
- •a positive methacholine test, defined as a PD20 of <1000 μg;
- •a positive test for exercise induced asthma defined as a fall in FEV1>15% after a standardised 6 min exercise test; and
- •a positive peak expiratory flow (PEF) variability , defined by ≥3 days or 2 consecutive days with a differences between morning and evening PEF of >20% during a 2-week period.
排除标准
- •Hospitalization for asthma within 3 months,
- •Asthma exacerbation during the last month,
- •Changes in asthma medication within 30 days of screening
- •A smoking history > 10 pack-years and smoking within the last year.
结局指标
主要结局
The change in the Asthma Quality of Life Questionnaire(AQLQ)
时间窗: Assesment of quality of life was perfomed at baseline, at week 26 and at week 52.
AQLQ is self-administered questionnaire which consists of 32 questions in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). Patients responded to each question on a seven point scale (7=no impairment 1=maximal impairment) and recalled their experiences during the previous 2 weeks. The overall AQLQ score was the mean of all 32 questions. A change in score of ≥0.5 indicates the minimal important difference (MID) in AQLQ.
次要结局
- Asthma control questionnaire (ACQ)(At baseline, week 26 and week 52)
- EuroQol(EQ-5D)(At baseline, week 26 and week 52)
- Forced expiratory volume in 1 second(At baseline, week 26 and week 52)
- Asthma symptoms(Two weeks prior to week 2, 26 and 52.)
- Peak expiratory flow(Two weeks prior to week 2, 26 and 52.)
- Rescue medication usage(To weeks prior to week 2, 26 and 52)
- Total medication score(At baseline, at week 26 and week 52.)
- Blood eosinophils count(At baseline, at week 26 and week 52)
- Exhaled nitric oxide(At baseline, at week 26 and week 52)
- Serum eosinophil cationic protein(At baseline, at week 26 and week 52)
- PD20(At baseline, at week 26 and week 52)