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

NCT06481787 | Not Yet Recruiting

• 1 other identifier: KY20240613-03-KS-01
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastroesophageal Reflux Disease; Depression

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Adverse events during treatment

  Baseline and 8 weeks

Study Arms (2)

Vonorasan fumarate

EXPERIMENTAL

Vonorasan fumarate, 20 mg twice daily orally before meals for 8 weeks of treatment.

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.

Drug: Vonorasan Fumarate; Drug: Zuojin Pills

Interventions

Vonorasan Fumarate DRUG

Vonorasan fumarate is taken 30min before breakfast and dinner.

Vonorasan fumarate; Zuojin Pills combined with Vonorasan Fumarate

Zuojin Pills DRUG

Zuojin Pills should be taken 30min after breakfast and dinner.

Zuojin Pills combined with Vonorasan Fumarate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

MeSH Terms

Conditions

Gastroesophageal Reflux; Depression

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Behavioral Symptoms; Behavior

Study Officials

• wanli liu

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

yan wang

CONTACT

19801295220; 292615568@qq.com

wanli liu

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: June 30, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share