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

Launched by NANJING FIRST HOSPITAL, NANJING MEDICAL UNIVERSITY · Jun 28, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment for people who have gastroesophageal reflux disease (GERD) and mild depression. The researchers want to see if a combination of a traditional Chinese medicine called Zuojin Wan and a medication called vornodine fumarate can help improve symptoms for these patients. They will also compare how well patients stick to their treatment and any side effects they might experience from either of the treatments.

To be eligible for this study, participants need to be between 18 and 65 years old, have a diagnosis of GERD, and meet certain criteria for mild depression. They should not have certain other health issues or take medications that could affect the study results. If someone joins the trial, they can expect to be part of a group that receives either the new treatment or the comparison medication, and they will be monitored for their symptoms and any reactions to the medications. It’s important to know that the trial has not started recruiting participants yet.

Gender

ALL

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.