A Single-centre Randomised Controlled Study of 4-week Zuojin Pills in Combination With Sodium Rabeprazole Enteric-coated Tablets or Mosapride Citrate for the Treatment of Functional Dyspepsia Combined With Depression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Depressionsymptom scale
研究概览
简要总结
To evaluate the symptom improvement of Zuojinwan combined with rabeprazole or Zuojinwan combined with a mosapride regimen in patients with functional dyspepsia combined with depression (liver-stomach depression-heat type) using rabeprazole or mosapride regimen as a control, and to compare the patients' adherence to the medication and the adverse effects between the two groups.
详细描述
Functional dyspepsia (FD) is the highest incidence of functional gastrointestinal disorders (FGIDs), of which the prevalence of FD combined with depression is 16.4%~22.8%, FD etiology is complex and diverse, and in the "Functional Gastrointestinal Disease Rome IV Diagnostic Criteria" released in 2016, it is clearly proposed that its nature is "brain-gut interaction disorder". The "Rome IV Diagnostic Criteria for Functional Gastrointestinal Diseases" released in 2016 explicitly proposed that its essence is "brain-gut interaction disorder", and it is due to the bidirectional regulation of the brain-gut axis that the phenomenon of combined depression is common in FD patients induced by "brain-gut interaction disorder", which is prone to clinical underdiagnosis and misdiagnosis, and also to clinical depression. It is easy to cause clinical underdiagnosis and misdiagnosis, and also brings many challenges to drug treatment. It is feasible to use Zuojinwan combined with rabeprazole sodium enteric-coated capsules or Zuojinwan combined with mosapride citrate tablets for the treatment of FD combined with depression. The aim of this study is to compare the efficacy of Zuojinwan combined with rabeprazole sodium enteric-coated capsules or mosapride citrate for the treatment of FD combined with depression with that of rabeprazole sodium enteric-coated capsules or mosapride citrate treatment 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
- •(1) Aged between 18 and 65 years; (2) Fulfilment of western medical diagnostic criteria for FD; (3) Meeting the diagnostic criteria for mild depression; (4) Comply with the diagnostic criteria of Liver and Stomach Depression and Heat Disorder in Chinese medicine; (5) A score of 7-17 on the 17-item Hamilton Depression Scale (HAMD-17) (7-17 being mild depression); (6) Good compliance and autonomous behaviour; (7) Enrolled patients must have a diagnosis of gastroscopy, and the gastroscopic diagnosis should be no abnormality or chronic gastritis, no obvious erosion can be seen under the microscope, and there is no obvious atrophy, intestinal epithelial metaplasia, or heterogeneous hyperplasia in the pathological examination. It should be based on the results of gastroscopy in a tertiary-level hospital within 6 months.
排除标准
- •(1) HP-positive patients; (2) Dyspepsia caused by organic diseases of the digestive system, such as peptic ulcer, reflux oesophagitis, erosive gastritis (grade 2 or above), atrophic gastritis, gastrointestinal tract tumour, gastrointestinal haemorrhage, hepatic, gallbladder and pancreatic diseases, intestinal obstruction, inflammatory bowel disease, and so on; (3) Systemic diseases affecting the dynamics of the digestive tract, such as diabetes mellitus, chronic renal insufficiency, connective tissue disease, neurological lesions, etc; (4) Those with severe primary heart, brain, liver, lung, kidney, blood or serious diseases affecting their survival; (5) Those with depression, suicidal tendencies and mental disorders who cannot cooperate; (6) Pregnant and breastfeeding women, patients with recent birth plans; (7) Taking drugs that have an effect on the results of this study within 2 weeks before participating in this study; (8) Those who are allergic to or have adverse reactions to the drugs in this study.
研究组 & 干预措施
rabeprazole sodium enteric-coated tablets or mosapride citrate
For epigastric pain syndrome, Rabeprazole sodium enteric-coated tablets were given as 20mg/dose, 2 times/day.
Postprandial discomfort syndrome was treated with mosapride citrate, 5mg/dose, 3 times/day, orally before meals.
The treatment lasted for 4 weeks.
干预措施: Rabeprazole sodium enteric-coated tablets (Drug)
rabeprazole sodium enteric-coated tablets or mosapride citrate
For epigastric pain syndrome, Rabeprazole sodium enteric-coated tablets were given as 20mg/dose, 2 times/day.
Postprandial discomfort syndrome was treated with mosapride citrate, 5mg/dose, 3 times/day, orally before meals.
The treatment lasted for 4 weeks.
干预措施: mosapride citrate (Drug)
Chinese medicine combination group
In the Chinese medicine combination group, 3g of Zuojinwan was added to the western medicine group twice a day for 4 weeks.
干预措施: zuojinwan (Drug)
Chinese medicine combination group
In the Chinese medicine combination group, 3g of Zuojinwan was added to the western medicine group twice a day for 4 weeks.
干预措施: Rabeprazole sodium enteric-coated tablets (Drug)
Chinese medicine combination group
In the Chinese medicine combination group, 3g of Zuojinwan was added to the western medicine group twice a day for 4 weeks.
干预措施: mosapride citrate (Drug)
结局指标
主要结局
Depressionsymptom scale
时间窗: Pre-treatment and 4 weeks of treatment
Hamilton Depression Scale is assessed patients' depressive symptoms pre- and post-treatment.
FD symptom scale
时间窗: Pre-treatment and 4 weeks of treatment
The overall score method for the main symptoms was used, and the overall symptoms included postprandial fullness and discomfort, early satiety, mid-upper abdominal pain, and burning sensation in the mid-upper abdomen. The degree and frequency of symptoms were observed before and after treatment
Chinese Medicine Symptoms
时间窗: Pre-treatment and 4 weeks of treatment
Evaluation of Chinese medicine symptoms before and after treatment using the Chinese Medicine Symptoms Score Scale
次要结局
- Adverse events during treatment(Pre-treatment and 4 weeks of treatment)