Functional DyspepsiaNCT06481371
Zuojin Wan Combined With Rabeprazole or Mosapride for the Treatment of Functional Dyspepsia Combined With Depression
A study testing zuojinwan, Rabeprazole sodium enteric-coated tablets and mosapride citrate in people with Functional Dyspepsia and Depression, run by Nanjing First Hospital, Nanjing Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Functional Dyspepsia, Depression
- What is being tested?
- zuojinwan, Rabeprazole sodium enteric-coated tablets and mosapride citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Functional Dyspepsia, Depression
- Being tested
- zuojinwan, Rabeprazole sodium enteric-coated tablets, mosapride citrate
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zuojinwanDrug
Also called zuojin pills
In the Chinese medicine combination group, 3g of Zuojinwan was added to the western medicine group twice a day for 4 weeks.
Rabeprazole sodium enteric-coated tabletsDrug
For epigastric pain syndrome
mosapride citrateDrug
Postprandial discomfort syndrome
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: zuojinwan; Drug: Rabeprazole sodium enteric-coated tablets; Drug: mosapride citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressionsymptom scale
Hamilton Depression Scale is assessed patients' depressive symptoms pre- and post-treatment.
Measured: 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
Measured: 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
Measured: Pre-treatment and 4 weeks of treatment
Secondary outcomes (1)
Adverse events during treatment
Ask patients about the occurrence of adverse events during treatment
Measured: Pre-treatment and 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start30 Jun 2024 (estimated)
- Primary completion27 Feb 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- wanli liu, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481371
- Sponsor's protocol ID
- KY20240613-02-KS-01
- Status last verified
- Jun 2024
- First submitted
- 25 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06481371
- Acronym / sponsor ID
- KY20240613-02-KS-01
- Conditions
- Functional Dyspepsia, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 27 Feb 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rabeprazole sodium enteric-coated tablets or mosapride citrate | Experimental | Drug: Rabeprazole sodium enteric-coated tablets, Drug: mosapride citrateFor 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. |
| Chinese medicine combination group | Experimental | Drug: zuojinwan, Drug: Rabeprazole sodium enteric-coated tablets, Drug: mosapride citrateIn the Chinese medicine combination group, 3g of Zuojinwan was added to the western medicine group twice a day for 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zuojinwanAlso: zuojin pillsIn the Chinese medicine combination group, 3g of Zuojinwan was added to the western medicine group twice a day for 4 weeks. | Drug | Chinese medicine combination group |
| Rabeprazole sodium enteric-coated tabletsFor epigastric pain syndrome | Drug | Chinese medicine combination group, rabeprazole sodium enteric-coated tablets or mosapride citrate |
| mosapride citratePostprandial discomfort syndrome | Drug | Chinese medicine combination group, rabeprazole sodium enteric-coated tablets or mosapride citrate |
Primary outcome
Depressionsymptom scale
Time frame: Pre-treatment and 4 weeks of treatment
Hamilton Depression Scale is assessed patients' depressive symptoms pre- and post-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
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
1 secondary outcome
Adverse events during treatment
Time frame: Pre-treatment and 4 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wanli liu study director
The First Affiliated Hospital with Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
A study testing zuojinwan, Rabeprazole sodium enteric-coated tablets and mosapride citrate in people with Functional Dyspepsia and Depression, run by Nanjing First Hospital, Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yan wang (19801295220, 292615568@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressionsymptom scale (time frame: Pre-treatment and 4 weeks of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.