A Single-centre Randomised Controlled Study of 8-week Zuojinwan in Combination With Volnoxan Fumarate for the Treatment of Gastro-oesophageal Reflux Disease Combined With Depression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Hamilton Depression Scale
研究概览
简要总结
To evaluate the improvement of symptoms in patients with gastroesophageal reflux disease combined with depression (hepatic and gastric depression-heat type) by Zuojin Wan combined with vornodine fumarate regimen as a control, and to compare the adherence to the medication and the adverse reactions of the patients between the two groups.
详细描述
Gastroesophageal reflux disease (GERD) is a common digestive disorder, and in recent years studies have shown an increasing incidence of comorbid depression in patients with GERD. The treatment of gastric acid inhibition and mucosal protection alone is not effective for patients with reflux combined with depression, and the additional administration of neuromodulatory drugs will increase the incidence of adverse reactions, so the combination of traditional Chinese medicine may be one of the effective ways to solve the above problems. The aim of this study was to compare the efficacy of Zuojin Wan combined with vunorasan fumarate with that of vunorasan fumarate alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 65 years;
- •Fulfilment of western medical diagnostic criteria for GERD;
- •Meet the diagnostic criteria for mild depression;
- •Comply with the diagnostic criteria of Liver and Stomach Depression-Heat syndrome in Chinese medicine;
- •A score of 7-17 on the 17-item Hamilton Depression Scale (HAMD-17) (7-17 being mild depression);
- •Good compliance and autonomous behaviour;
- •No medications that may have an effect on the study, such as acid-suppressing agonists, were taken within 2 weeks prior to enrolment;
排除标准
- •HP positive patients;
- •Other organic diseases of the digestive system, such as peptic ulcer, peptic tumour, peptic haemorrhage, liver, gallbladder and pancreas disease, intestinal obstruction and inflammatory bowel disease;
- •Systemic diseases affecting the dynamics of the digestive tract, such as diabetes mellitus, chronic renal insufficiency, connective tissue diseases, neurological lesions, etc;
- •Pathological diagnosis of the esophageal mucosa suggestive of moderate-to-severe heterogeneous hyperplasia;
- •Previous surgery resulting in a decrease in gastric acid or a history of oesophageal or gastric surgery;
- •Varicose veins in the esophagus or fundus of the stomach;
- •Persons with severe primary heart, brain, liver, lung, kidney, blood or serious disease affecting their survival;
- •Those with depression, suicidal tendencies and mental disorders who cannot cooperate;
- •Pregnant or breastfeeding women, or patients who have a plan to have children in the near future;
- •Taking drugs that have an effect on the results of this study within 2 weeks before participating in this study;
- •Allergy or adverse reaction to the study drug.
研究组 & 干预措施
Vonorasan fumarate
Vonorasan fumarate, 20 mg twice daily orally before meals for 8 weeks of treatment.
干预措施: Vonorasan Fumarate (Drug)
Zuojin Pills combined with Vonorasan Fumarate
Add Zuojin Pills, 3g each time, twice daily, on top of Vonorasan Fumarate treatment for 8 weeks.
干预措施: Vonorasan Fumarate (Drug)
Zuojin Pills combined with Vonorasan Fumarate
Add Zuojin Pills, 3g each time, twice daily, on top of Vonorasan Fumarate treatment for 8 weeks.
干预措施: Zuojin Pills (Drug)
结局指标
主要结局
Hamilton Depression Scale
时间窗: Baseline and 8 weeks
Assessing patients for depressive symptoms
Chinese Medicine Points Scale
时间窗: Baseline and 8 weeks
Assessment of TCM evidence before and after treatment
Reflux Disease Questionnaire
时间窗: Baseline and 8 weeks
According to the frequency and severity of episodes of the main symptoms，observe the changes of reflux'disease questionnaire score before treatment and after 8 weeks of treatment.
次要结局
- Adverse events during treatment(Baseline and 8 weeks)