Clinical trial NCT06481371: Zuojin Wan Combined With Rabeprazole or Mosapride for the Treatment of Functional Dyspepsia Combined With Depression
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Functional Dyspepsia
Depression
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* (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.

Exclusion Criteria:

* (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.

Primary outcomes:
measure: Depressionsymptom scale
timeFrame: Pre-treatment and 4 weeks of treatment
measure: FD symptom scale
timeFrame: Pre-treatment and 4 weeks of treatment
measure: Chinese Medicine Symptoms
timeFrame: Pre-treatment and 4 weeks of treatment
Secondary outcomes:
measure: Adverse events during treatment
timeFrame: Pre-treatment and 4 weeks of treatment
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: wanli liu
role: STUDY_DIRECTOR
References: