An open label (pre and post- homoeopathic intervention) study to evaluate efficacy of homoeopathic treatment of Non erosive gastro esophageal reflux disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
-  Resolution of symptoms in terms of severity and frequency.
研究概览
简要总结
The study will be conducted with an objective to find out the usefullness of the Homoeopathic medicine in the treatment of Non erosive gastro-esophageal reflux disease. 30 patients between the age group of 18 years to 62 years presenting with two major symptoms i.e. hegurgitation and heartburn with symptom score more than 4 and having normal endoscopic findings will be enrolled during the study. The study is multicentric open label pre-post homoeopathic intervention where individualized homoeopathic medicine will be given and patients will be assessed on weekly basis till 8 weeks. The outcome will be measured in terms of improvement in GERD-based symptom score baseline to end of treatment, resolution of symptom in terms of severity and frequency, quality of life using WHO-QOL BREF and relief in pain will be assessed by VAS score.
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
- 18.00 Year(s) 至 62.00 Year(s)（—）
- 性别
- All
入选标准
- •ï‚§ Patient presenting with heartburn & regurgitation with symptom score of more than 4 with normal endoscopic finding.
- •ï‚§ Patient having history of heart burn & regurgitation for 6 weeks with minimum of 2 episodes in a week.
排除标准
- •ï‚§ Pregnancy or lactation period.
- •ï‚§ Patients having: Dysphagia or associated alarm symptoms like gastrointestinal hemorrhage, mechanical obstruction or perforation.
- •ïƒ¼Peptic ulcer disease.
- •ïƒ¼Severe cardiac, pulmonary, hepatic or renal disease.
- •ïƒ¼Presence of gall stone disease.
- •ï‚§ Patient on concomitant medications known to affect the treatment response or recent h/o consumption of systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs), Proton Pump Inhibitors and histamine 2-receptor antagonists within the previous 15 days.
- •ï‚§ Patients with history of previous surgery of gastrointestinal tract excluding appendectomy, cholecystectomy and polypectomy.
结局指标
主要结局
 Resolution of symptoms in terms of severity and frequency.
时间窗: the outcome will be assessed at 56th week(at the end of treatment)
 To assess the quality of life by WHO-QOL BREF.
时间窗: the outcome will be assessed at 56th week(at the end of treatment)
 Improvement in GERD -based symptom score from baseline to end of treatment.
时间窗: the outcome will be assessed at 56th week(at the end of treatment)
次要结局
- To deduce symptom of the drugs found effective.(At the end of study)