Gastroesophageal Reflux DiseaseNCT06481787
Zuojin Wan Combined With Woonosan Fumarate for the Treatment of GRD Combined With Depression
A study testing Vonorasan Fumarate and Zuojin Pills in people with Gastroesophageal Reflux Disease and Depression, run by Nanjing First Hospital, Nanjing Medical University.
Trial summary
To evaluate the improvement of symptoms in patients with gastroesophageal reflux disease combined with depression (hepatic and gastric depression-heat type) by Zuojin Wan combined with vornodine fumarate regimen as a control, and to compare the adherence to the medication and the adverse reactions of the patients… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux Disease, Depression
- What is being tested?
- Vonorasan Fumarate and Zuojin Pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2024to 30 Jun 2026
- 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
- Aged between 18 and 65 years;
- Fulfilment of western medical diagnostic criteria for GERD;
- Meet the diagnostic criteria for mild depression;
- Comply with the diagnostic criteria of Liver and Stomach Depression-Heat syndrome in Chinese medicine;
- A score of 7-17 on the 17-item Hamilton Depression Scale (HAMD-17) (7-17 being mild depression);
- Good compliance and autonomous behaviour;
- No medications that may have an effect on the study, such as acid-suppressing agonists, were taken within 2 weeks prior to enrolment;
Who cannot join
- HP positive patients;
- Other organic diseases of the digestive system, such as peptic ulcer, peptic tumour, peptic haemorrhage, liver, gallbladder and pancreas disease, intestinal obstruction and inflammatory bowel disease;
- Systemic diseases affecting the dynamics of the digestive tract, such as diabetes mellitus, chronic renal insufficiency, connective tissue diseases, neurological lesions, etc;
- Pathological diagnosis of the esophageal mucosa suggestive of moderate-to-severe heterogeneous hyperplasia;
- Previous surgery resulting in a decrease in gastric acid or a history of oesophageal or gastric surgery;
- Varicose veins in the esophagus or fundus of the stomach;
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- Persons with severe primary heart, brain, liver, lung, kidney, blood or serious disease affecting their survival;
- Those with depression, suicidal tendencies and mental disorders who cannot cooperate;
- Pregnant or breastfeeding women, or patients who have a plan to have children in the near future;
- Taking drugs that have an effect on the results of this study within 2 weeks before participating in this study;
- Allergy or adverse reaction to the study drug.
Trial locations and contacts
No sites are listed yet.
wanli liu contact
About this study
Official title: A Single-centre Randomised Controlled Study of 8-week Zuojinwan in Combination With Volnoxan Fumarate for the Treatment of Gastro-oesophageal Reflux Disease Combined With Depression
To evaluate the improvement of symptoms in patients with gastroesophageal reflux disease combined with depression (hepatic and gastric depression-heat type) by Zuojin Wan combined with vornodine fumarate regimen as a control, and to compare the adherence to the medication and the adverse reactions of the patients between the two groups.
Read the detailed description
Gastroesophageal reflux disease (GERD) is a common digestive disorder, and in recent years studies have shown an increasing incidence of comorbid depression in patients with GERD. The treatment of gastric acid inhibition and mucosal protection alone is not effective for patients with reflux combined with depression, and the additional administration of neuromodulatory drugs will increase the incidence of adverse reactions, so the combination of traditional Chinese medicine may be one of the effective ways to solve the above problems. The aim of this study was to compare the efficacy of Zuojin Wan combined with vunorasan fumarate with that of vunorasan fumarate alone.
- Conditions
- Gastroesophageal Reflux Disease, Depression
- Being tested
- Vonorasan Fumarate, Zuojin Pills
- Medical subject headings
- Gastroesophageal Reflux, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonorasan FumarateDrug
Vonorasan fumarate is taken 30min before breakfast and dinner.
Zuojin PillsDrug
Zuojin Pills should be taken 30min after breakfast and dinner.
| Study group | Role | What they receive |
|---|---|---|
| Vonorasan fumarate | Experimental | Vonorasan fumarate, 20 mg twice daily orally before meals for 8 weeks of treatment. Receives: Drug: Vonorasan Fumarate |
| Zuojin Pills combined with Vonorasan Fumarate | Experimental | Add Zuojin Pills, 3g each time, twice daily, on top of Vonorasan Fumarate treatment for 8 weeks. Receives: Drug: Vonorasan Fumarate; Drug: Zuojin Pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflux Disease Questionnaire
According to the frequency and severity of episodes of the main symptoms，observe the changes of reflux'disease questionnaire score before treatment and after 8 weeks of treatment.
Measured: Baseline and 8 weeks
Hamilton Depression Scale
Assessing patients for depressive symptoms
Measured: Baseline and 8 weeks
Chinese Medicine Points Scale
Assessment of TCM evidence before and after treatment
Measured: Baseline and 8 weeks
Secondary outcomes (1)
Adverse events during treatment
Ask the patient about the occurrence of adverse events while taking the medication
Measured: Baseline and 8 weeks
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 completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- 300 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
- NCT06481787
- Sponsor's protocol ID
- KY20240613-03-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 8-week Zuojinwan in Combination With Volnoxan Fumarate for the Treatment of Gastro-oesophageal Reflux Disease Combined With Depression
- ClinicalTrials.gov ID
- NCT06481787
- Acronym / sponsor ID
- KY20240613-03-KS-01
- Conditions
- Gastroesophageal Reflux Disease, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (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 improvement of symptoms in patients with gastroesophageal reflux disease combined with depression (hepatic and gastric depression-heat type) by Zuojin Wan combined with vornodine fumarate regimen as a control, and to compare the adherence to the medication and the adverse reactions of the patients between the two groups.
Detailed description
Gastroesophageal reflux disease (GERD) is a common digestive disorder, and in recent years studies have shown an increasing incidence of comorbid depression in patients with GERD. The treatment of gastric acid inhibition and mucosal protection alone is not effective for patients with reflux combined with depression, and the additional administration of neuromodulatory drugs will increase the incidence of adverse reactions, so the combination of traditional Chinese medicine may be one of the effective ways to solve the above problems. The aim of this study was to compare the efficacy of Zuojin Wan combined with vunorasan fumarate with that of vunorasan fumarate alone.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vonorasan fumarate | Experimental | Drug: Vonorasan FumarateVonorasan fumarate, 20 mg twice daily orally before meals for 8 weeks of treatment. |
| Zuojin Pills combined with Vonorasan Fumarate | Experimental | Drug: Vonorasan Fumarate, Drug: Zuojin PillsAdd Zuojin Pills, 3g each time, twice daily, on top of Vonorasan Fumarate treatment for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged between 18 and 65 years;
- Fulfilment of western medical diagnostic criteria for GERD;
- Meet the diagnostic criteria for mild depression;
- Comply with the diagnostic criteria of Liver and Stomach Depression-Heat syndrome in Chinese medicine;
- A score of 7-17 on the 17-item Hamilton Depression Scale (HAMD-17) (7-17 being mild depression);
Key exclusion criteria (11 listed)
- HP positive patients;
- Other organic diseases of the digestive system, such as peptic ulcer, peptic tumour, peptic haemorrhage, liver, gallbladder and pancreas disease, intestinal obstruction and inflammatory bowel disease;
- Systemic diseases affecting the dynamics of the digestive tract, such as diabetes mellitus, chronic renal insufficiency, connective tissue diseases, neurological lesions, etc;
- Pathological diagnosis of the esophageal mucosa suggestive of moderate-to-severe heterogeneous hyperplasia;
- Previous surgery resulting in a decrease in gastric acid or a history of oesophageal or gastric surgery;
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 |
|---|---|---|
| Vonorasan FumarateVonorasan fumarate is taken 30min before breakfast and dinner. | Drug | Vonorasan fumarate, Zuojin Pills combined with Vonorasan Fumarate |
| Zuojin PillsZuojin Pills should be taken 30min after breakfast and dinner. | Drug | Zuojin Pills combined with Vonorasan Fumarate |
Primary outcome
Reflux Disease Questionnaire
Time frame: Baseline and 8 weeks
According to the frequency and severity of episodes of the main symptoms，observe the changes of reflux'disease questionnaire score before treatment and after 8 weeks of treatment.
Hamilton Depression Scale
Time frame: Baseline and 8 weeks
Assessing patients for depressive symptoms
Chinese Medicine Points Scale
Time frame: Baseline and 8 weeks
Assessment of TCM evidence before and after treatment
1 secondary outcome
Adverse events during treatment
Time frame: Baseline and 8 weeks
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 contact
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 Vonorasan Fumarate and Zuojin Pills in people with Gastroesophageal Reflux Disease 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 7 inclusion and 11 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?
Reflux Disease Questionnaire (time frame: Baseline and 8 weeks). 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.