Biliary reflux gastritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: In accordance with the "Consensus Opinion on Chinese Chronic Gastritis" (2017) by the Working Group on Chronic Gastritis of the Chinese Society of Gastroenterology and the "Expert Consensus on the Diagnosis and Treatment of Chronic Gastritis in Traditional Chinese Medicine" (2023) by the Subcommittee of Diseases of the Chinese Association of Traditional Chinese Medicine, the inclusion criteria are as follows: 1. Meets the diagnostic criteria for biliary reflux gastritis as specified in the "Consensus Opinion on Chinese Chronic Gastritis" (2017), with confirmed evidence of bile reflux via endoscopic examination and inflammatory changes in the gastric mucosa. 2. Meets the diagnostic criteria for traditional Chinese medicine (TCM) diseases as specified in the "Expert Consensus on the Diagnosis and Treatment of Chronic Gastritis in Traditional Chinese Medicine" (2023), falling under the categories of "gaotong (stomach pain)," "gaopi disease (stagnation of qi in the stomach)," and "noisy stomach." The primary symptoms include epigastric pain (distending pain, dull pain, burning pain, stabbing pain, with or without tenderness), upper abdominal distension, or a burning sensation, accompanied by symptoms such as emotional distress, acid regurgitation, gastric burning, and belching. 3. Age between 18 and 70 years, with no restriction on gender. 4. Patients have signed an informed consent form, voluntarily participating in this study and agreeing to follow-up.
Exclusion criteria
Exclusion criteria: 1.Patients with peptic ulcers, gastric tumors, or other severe gastric diseases; 2. Patients with cirrhosis, acute cholecystitis, or other severe hepatobiliary or pancreatic diseases; 3. Patients with severe cardiovascular, cerebrovascular, hepatic, or renal diseases involving major organs; 4. Pregnant or breastfeeding women; 5. Patients with a history of allergies, such as allergies to two or more drugs or foods, or known allergy to the study drug; 6. Patients who have used medications affecting gastrointestinal motility or gastric mucosal protection, which may impact the evaluation of the study's efficacy, within the past two weeks; 7. Patients with mental disorders or poor compliance, making it impossible to complete the study; 8. Legally defined disabled patients (blindness, deafness, mutism, intellectual disabilities, mental disorders, physical disabilities); 9. Patients with a suspected or confirmed history of alcohol or substance abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of bile reflux under gastroscopy.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Endoscopic severity of mucosal inflammation;TCM Syndrome Score;blood indicators; | — |
Countries
China
Contacts
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University