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

NCT06481371 | Not Yet Recruiting

• 1 other identifier: KY20240613-02-KS-01
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Functional Dyspepsia; Depression

Outcome Measures

Primary Outcomes (3)

• Depressionsymptom scale

  Hamilton Depression Scale is assessed patients' depressive symptoms pre- and post-treatment.

  Pre-treatment and 4 weeks of treatment

• FD symptom scale

  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

  Evaluation of Chinese medicine symptoms before and after treatment using the Chinese Medicine Symptoms Score Scale

  Pre-treatment and 4 weeks of treatment

Secondary Outcomes (1)

• Adverse events during treatment

  Pre-treatment and 4 weeks of treatment

Study Arms (2)

rabeprazole sodium enteric-coated tablets or mosapride citrate

EXPERIMENTAL

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; Drug: mosapride citrate

Chinese medicine combination group

EXPERIMENTAL

In the Chinese medicine combination group, 3g of Zuojinwan was added to the western medicine group twice a day for 4 weeks.

Drug: zuojinwan; Drug: Rabeprazole sodium enteric-coated tablets; Drug: mosapride citrate

Interventions

zuojinwan DRUG

In the Chinese medicine combination group, 3g of Zuojinwan was added to the western medicine group twice a day for 4 weeks.

Also known as: zuojin pills

Chinese medicine combination group

Rabeprazole sodium enteric-coated tablets DRUG

For epigastric pain syndrome

Chinese medicine combination group; rabeprazole sodium enteric-coated tablets or mosapride citrate

mosapride citrate DRUG

Postprandial discomfort syndrome

Chinese medicine combination group; rabeprazole sodium enteric-coated tablets or mosapride citrate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

MeSH Terms

Conditions

Depression

Interventions

mosapride

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• wanli liu

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

yan wang

CONTACT

19801295220; 292615568@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: June 30, 2024
• Primary Completion: February 27, 2025
• Study Completion: April 30, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share