Zuojin Wan Combined With Woonosan Fumarate for the Treatment of GRD Combined With Depression
June 28, 2024 updated by: Nanjing First Hospital, Nanjing Medical University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
300
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
- Name: yan wang
- Phone Number: 19801295220
- Email: 292615568@qq.com
Study Contact Backup
- Name: wanli liu
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:
- 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;
Exclusion Criteria:
- 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;
- 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.
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: Vonorasan fumarate
Vonorasan fumarate, 20 mg twice daily orally before meals for 8 weeks of treatment.
|
Vonorasan fumarate is taken 30min before breakfast and dinner.
|
|
Experimental: Zuojin Pills combined with Vonorasan Fumarate
Add Zuojin Pills, 3g each time, twice daily, on top of Vonorasan Fumarate treatment for 8 weeks.
|
Vonorasan fumarate is taken 30min before breakfast and dinner.
Zuojin Pills should be taken 30min after breakfast and dinner.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 8 weeks
|
|
Hamilton Depression Scale
Time Frame: Baseline and 8 weeks
|
Assessing patients for depressive symptoms
|
Baseline and 8 weeks
|
|
Chinese Medicine Points Scale
Time Frame: Baseline and 8 weeks
|
Assessment of TCM evidence before and after treatment
|
Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse events during treatment
Time Frame: Baseline and 8 weeks
|
Ask the patient about the occurrence of adverse events while taking the medication
|
Baseline and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
April 30, 2026
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
June 25, 2024
First Submitted That Met QC Criteria
June 28, 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 28, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20240613-03-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
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