Effectiveness of individualized homoeopathic medicine in management of cases of GERD with particular emphasis on Bilious temperament: A prospective single arm clinical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To assess the reduction of clinical symptoms of GERD using GERDQ scale
研究概览
简要总结
Gastroesophageal reflux disease (GERD) is a prevalent health issue resulting from the backflow of stomach contents into the esophagus due to a malfunctioning lower esophageal sphincter (LES). This reflux can cause uncomfortable symptoms such as heartburn and regurgitation, and over time, may damage the esophageal lining due to acidic exposure.
Research question- Is there any significant role of individualized homoeopathic medicine in management of cases of GERD in bilious temperament.
Null hypothesis- There is significant role of individualized homoeopathic medicine in management of cases of GERD in bilious temperament.
Alternative hypothesis- There is no significant role of individualized homoeopathic medicine in management of cases of GERD in bilious temperament.
Aim- To study effectiveness of individualized homoeopathic medicines in management of cases of GERD in bilious temperament.
Primary objective- To evaluate effectiveness of individualized homoeopathic medicines in management of cases of GERD in bilious temperament using GERDQ scale.
Secondary objective- 1) To identify useful homoeopathic medicines for management of GERD in bilious temperament. 2) To identify most commonly indicated medicine in management of GERD in bilious temperament.
Source of data- Out patient department of Nehru Homoeopathic Medical College and Hospital
Study duration- 1 year
Study design- Open label, prospective, single arm clinical study
Sample size- 40
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients between age group 18–60 years having symptoms of heartburn and/or regurgitation with at least 1 episode in a week and symptom score more than 4 on GERDQ.
- •Patient having bilious temperament on the basis of temperament questionnaire.
- •Patients willing to provide written informed consent.
排除标准
- •Patients falling under other temperaments as per questionnaire.
- •Patients with advanced pathology of GERD.
- •Substance abuse or dependence.
- •Patients already taking acid-suppressing medications like proton pump inhibitors (PPIs) and histamine H2 receptor antagonists.
- •Patients of malignancy.
- •Patients who are terminally ill, under immunosuppressive treatment or self-reported immunocompromised state.
- •Diagnosed case of mental illness / psychiatric/ other uncontrolled/ life threatening illness affecting quality of life/any organ failure.
- •Patient unable to comply with the study protocol (including psychiatric diseases).
- •Pregnant ladies are excluded.
- •Unwilling to take part and not giving consent to join the study.
结局指标
主要结局
To assess the reduction of clinical symptoms of GERD using GERDQ scale
时间窗: Baseline and at every month
次要结局
- To identify useful homeopathic medicines for management of GERD in bilious temperament.(At 1 year)
- To identify the most commonly indicated medicine in management of GERD in bilious temperament.(At 1 year)
研究者
Dr Kushal
Nehru Homoeopathic Medical College and Hospital