Zuojin Wan Combined With Rabeprazole or Mosapride for the Treatment of Functional Dyspepsia Combined With Depression

June 25, 2024 updated by: Nanjing First Hospital, Nanjing Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Rabeprazole sodium enteric-coated tablets
For epigastric pain syndrome
Drug: mosapride citrate
Postprandial discomfort syndrome
Experimental: 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.
Drug: Rabeprazole sodium enteric-coated tablets
For epigastric pain syndrome
Drug: mosapride citrate
Postprandial discomfort syndrome
Drug: zuojinwan
In the Chinese medicine combination group, 3g of Zuojinwan was added to the western medicine group twice a day for 4 weeks.
Other Names:
  • zuojin pills

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressionsymptom scale
Time Frame: Pre-treatment and 4 weeks of treatment
Hamilton Depression Scale is assessed patients' depressive symptoms pre- and post-treatment.
Pre-treatment and 4 weeks of treatment
FD symptom scale
Time Frame: 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
Pre-treatment and 4 weeks of treatment
Chinese Medicine Symptoms
Time Frame: Pre-treatment and 4 weeks of treatment
Evaluation of Chinese medicine symptoms before and after treatment using the Chinese Medicine Symptoms Score Scale
Pre-treatment and 4 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events during treatment
Time Frame: Pre-treatment and 4 weeks of treatment
Ask patients about the occurrence of adverse events during treatment
Pre-treatment and 4 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

  • Study Director: wanli liu, The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2024

Primary Completion (Estimated)

February 27, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Actual)

July 1, 2024

Last Update Submitted That Met QC Criteria

June 25, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20240613-02-KS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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