Effectiveness of Individualized Homoeopathic Medicine in Comparison with Quassia amara 30C in the Treatment of Gastroesophageal Reflux Disease: A Double Blind Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- To compare changes in the GERD Health-Related Quality of Life (GERD- HRQL) Questionnaire score in the patient suffering from GERD treated with Individualized Homoeopathic Medicine and Quassia amara-30C over 3 months.
研究概览
简要总结
Gastroesophageal reflux disease is a common condition causing uncomfortable symptoms. GERD can cause a wide variety of symptoms ranging from heartburn and regurgitation to more atypical symptoms such as cough, chest pain, and hoarseness. In old school Quassia amara bark was used for dyspepsia. Boericke mentions in his Materia Medica that it acts on the gastric organs as a tonic. Heartburn and gastralgia, regurgitation of food ,but no study paper available in Homoeopathy that proves its efficacy .So i will screen patients of GERD with no other complications of GERD. For one intervention group 41 patients i will give Quassia amara 30C and other 41 patients will take Individualized Homoeopathic treatment those who are attending NIH OPD & IPD, Kolkata. Study period will be 18 months and intervention period will be 3 months. After study i will compare GERD Health Related Quality of Life(GERD-HRQL) Questionnaire score and Perceived Stress Scale(PSS) Score in both Quassia and Individualized Homoeopathic Medicine group. Patient will be enrolled after informed consent only available in Hindi, English and Bengali languages. If any negative outcomes appears for deterioration of health condition of patients then study will be stopped and necessary measures for the betterment of patient will be taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient suffering from GERD diagnosed clinically and by GERD Questionnaire (GERD Q).
- •2.Patients aged between 20 to 65 years.
- •3.Patients of both sexes, all religions, and of different socioeconomic status.
排除标准
- •1.Pregnant and lactating women.
- •2.Patients who aren’t willing to lifestyle modification.
- •3.Patients having complications of GERD like dysphagia, food impaction, etc.
- •4.Patients having any terminal disease condition like cancer, end-stage renal disease, etc.
- •5.Patients not willing to take part in the study.
结局指标
主要结局
To compare changes in the GERD Health-Related Quality of Life (GERD- HRQL) Questionnaire score in the patient suffering from GERD treated with Individualized Homoeopathic Medicine and Quassia amara-30C over 3 months.
时间窗: baseline and 3 month
次要结局
- To compare changes in the Perceived Stress Scale (PSS) score in the patient suffering from GERD treated with Individualized Homoeopathic Medicine and Quassia amara-30C over 3 months.(Baseline and 3 month)
研究者
Jagannath Meher
National Institute of Homoeopathy