A Study of the Use of Combination of Anti-cholinergic and Minor Tranquilliser in the Treatment of Non-cardiac Chest Pain - a Double Blind Placebo Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Symptoms scores, quality of life
研究概览
简要总结
Non-cardiac chest pain is a common clinical problem encountered in our practice but at present, the results of treatments are unsatisfactory. The pathogenesis remains unknown but altered motility of the esophagus and psychological factors including anxiety have been implicated as important factors. Reports of the single use of anticholinergic drugs and anxiolytics have yielded conflicting results, has been demonstrated to yield marginal or of no value. However the use of the combination therapy, especially with a double blind fashion have not been reported. On that basis, we propose to use a combination of anti-cholinergic and tranquilliser for the symptomatic treatment of non-cardiac chest pain. The aim of this study is to evaluate the efficacy of combination therapy of anti-cholinergic and anxiolytic drugs in the treatment of non-cardiac chest pain.
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
- Double
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
- •Ambulatory patients over the age of 18
- •Patients who are normal endoscopically
- •Patients who do not have symptomatic reflux disease
- •Patient who have normal coronary angiogram or patient with normal exercise radionuclide scan or patient with normal persantin radionuclide scan.
排除标准
- •Patients with history of significant cardiac, renal, pulmonary or hepatic diseases,
- •Patients with history of dyspepsia or peptic ulcer diseases
- •Patient with documented reflux diseases.
- •Patient on drugs that affect gastrointestinal motility in the past 2 weeks
- •Patients who are pregnant or lactating
- •Patients who are suffering from costochrondritis
- •Patients who are known to be sensitive to benzodiazepine or anti-cholinergic
- •Patients with glaucoma and benign prostatic hypertrophy
结局指标
主要结局
Symptoms scores, quality of life
时间窗: 12 Weeks
次要结局
- Adverse effects(12 Weeks)
- Compliance(12 Weeks)