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

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: Depression; Gastroesophageal Reflux Disease
• Intervention / Treatment: Drug: Vonorasan Fumarate; Drug: Zuojin Pills

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

• Study Contact: Name: yan wang; Phone Number: 19801295220; Email: 292615568@qq.com
• Study Contact Backup: Name: wanli liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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.	Drug: Vonorasan Fumarate; 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.	Drug: Vonorasan Fumarate; Vonorasan fumarate is taken 30min before breakfast and dinner.; Drug: Zuojin Pills; 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	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	Assessing patients for depressive symptoms	Baseline and 8 weeks
Chinese Medicine Points Scale	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	Ask the patient about the occurrence of adverse events while taking the medication	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Study Director: wanli liu, The First Affiliated Hospital with Nanjing Medical University

Study record dates

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: Behavioral Symptoms; Mental Disorders; Digestive System Diseases; Mood Disorders; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Depression; Depressive Disorder; Gastroesophageal Reflux
• 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