Clinical trial NCT06481787: Zuojin Wan Combined With Woonosan Fumarate for the Treatment of GRD Combined With Depression
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Depression
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Aged between 18 and 65 years;
2. Fulfilment of western medical diagnostic criteria for GERD;
3. Meet the diagnostic criteria for mild depression;
4. Comply with the diagnostic criteria of Liver and Stomach Depression-Heat syndrome 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. 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:

1. HP positive patients;
2. 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;
3. Systemic diseases affecting the dynamics of the digestive tract, such as diabetes mellitus, chronic renal insufficiency, connective tissue diseases, neurological lesions, etc;
4. Pathological diagnosis of the esophageal mucosa suggestive of moderate-to-severe heterogeneous hyperplasia;
5. Previous surgery resulting in a decrease in gastric acid or a history of oesophageal or gastric surgery;
6. Varicose veins in the esophagus or fundus of the stomach;
7. Persons with severe primary heart, brain, liver, lung, kidney, blood or serious disease affecting their survival;
8. Those with depression, suicidal tendencies and mental disorders who cannot cooperate;
9. Pregnant or breastfeeding women, or patients who have a plan to have children in the near future;
10. Taking drugs that have an effect on the results of this study within 2 weeks before participating in this study;
11. Allergy or adverse reaction to the study drug.

Primary outcomes:
measure: Reflux Disease Questionnaire
timeFrame: Baseline and 8 weeks
measure: Hamilton Depression Scale
timeFrame: Baseline and 8 weeks
measure: Chinese Medicine Points Scale
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Adverse events during treatment
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: wanli liu
role: STUDY_DIRECTOR
References: