Zuojin Wan Combined With Woonosan Fumarate for the Treatment of GRD Combined With Depression

Not Applicable

Not yet recruiting

• Conditions: Gastroesophageal Reflux Disease; Depression
• Interventions: Drug: Vonorasan Fumarate; Drug: Zuojin Pills

• Registration Number: NCT06481787
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-25
• Study First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Study Start: 2024-06-30
• Study First Posted: 2024-07-01
• Last Update Posted: 2024-07-01
• Primary Completion: 2026-04-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zuojin Pills combined with Vonorasan Fumarate	Zuojin Pills	Add Zuojin Pills, 3g each time, twice daily, on top of Vonorasan Fumarate treatment for 8 weeks.
Vonorasan fumarate	Vonorasan Fumarate	Vonorasan fumarate, 20 mg twice daily orally before meals for 8 weeks of treatment.
Zuojin Pills combined with Vonorasan Fumarate	Vonorasan Fumarate	Add Zuojin Pills, 3g each time, twice daily, on top of Vonorasan Fumarate treatment for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Scale	Baseline and 8 weeks	Assessing patients for depressive symptoms
Chinese Medicine Points Scale	Baseline and 8 weeks	Assessment of TCM evidence before and after treatment
Reflux Disease Questionnaire	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.

Secondary Outcome Measures

Name	Time	Method
Adverse events during treatment	Baseline and 8 weeks	Ask the patient about the occurrence of adverse events while taking the medication