Effectiveness of Individualised Homoeopathic Medicines with Lifestyle Changes versus Placebo with Lifestyle Changes in the Treatment of Gastroesophageal Reflux Disease – A Randomised Crossover Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- To evaluate the change in GERD symptoms using the GERD questionnaire in both groups.
研究概览
简要总结
This study aims to evaluate the effectiveness of individualized homeopathic medicines combined with lifestyle changes compared to placebo with lifestyle changes in managing Gastroesophageal Reflux Disease (GERD). It uses a randomized crossover design where participants receive both interventions in different phases. Outcomes will be assessed using the GERD-Q and WHOQOL-BREF scales to measure symptom relief and quality of life. The study seeks to provide scientific evidence on the role of homeopathy with lifestyle modifications in GERD management Study duration is of 16 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 19.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing to participate and provide written informed consent.
- •Symptoms of heartburn and/or regurgitation for at least 3 months, with at least 2 episodes per week.
- •GERDQ score below 8.
排除标准
- •Participants with history of esophageal or gastric malignancy, peptic ulcer disease, gastrointestinal bleeding, or GI perforation Participants with hypertension, or cardiovascular diseases Psychiatric patients.
- •Participants under active medication for GERD or any systemic illness (cardiac, hepatic, renal, pulmonary) Pregnant and lactating women.
结局指标
主要结局
To evaluate the change in GERD symptoms using the GERD questionnaire in both groups.
时间窗: Enrollment of cases for 6 months | Follow up period for 6 months | Data analysis for 2 months | Record writing for 2 months
次要结局
- To measure the quality of life of patients pre- and post-treatment using WHO-QOL questionnaire(Enrollment of cases for 6 months)
研究者
Anushree
Bakson Homoeopathic Medical College and Hospital