Gastroesophageal reflux disease
Conditions
Interventions
Control group:Zhenni Huayu decoction placebo combined with rabeprazole capsules
Experimental group:Zhenni Huayu decoction combined with rabeprazole capsules
Sponsors
Yueyang Integrated Traditional Chinese and Western Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Patients aged >=18 years and <=70 years old regardless of gender; (2) meets the diagnostic criteria of GERD; (3)meet the diagnostic criteria of TCM liver-stomach stagnation-heat syndrome; (4) GERD-Q questionnaire score =8; (5) patients who meet the SAS and SDS assessment scales are mild to moderate: a standardized score of 50-70 on the Self-Anxiety Scale (SAS) and/or a standardized score of 53-72 on the Self-Depression Scale (SDS); (6) patient has signed Informed Consent Form.
Exclusion criteria
Exclusion criteria: (1) Confirmed diagnosis of peptic ulcer (A1-S1), erosive gastritis, or duodenal erosion (with erosion sites less than 5 points), or upper gastrointestinal tract tumors; patients with esophageal structural abnormalities, esophageal motility disorders, or positive Helicobacter pylori (HP) test results; (2) Patients with severe organic lesions in major organs such as heart, liver, lungs, or kidneys, or those with infectious, genetic, metabolic, endocrine, or autoimmune diseases; (3) Patients with a history of esophageal, gastric, or duodenal surgery (including resection); (4) Patients with severe mental disorders, severe mental or psychological diseases, or language barriers; (5) Patients with allergic constitutions or allergies to the drugs used in this study; (6) Patients in pregnancy, lactation, or intending to conceive; (7) Patients who have used proton pump inhibitors (PPIs) within one month prior to enrollment or have participated in other studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-Rating Anxiety Scale;Self-Rating Depression Scale;Clinical Symptom Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Electronic Gastroscopy;Interleukin-8;Gastrin;Interleukin-6;tumor necrosis factor-a;Pittsburgh sleep quality index;Gastroesophageal reflux disease questionnaire,GerdQ;24-hour esophageal impedance and pH monitoring; | — |
Countries
CHINA
Contacts
Public ContactZhou Bingduo
Yueyang Integrated Traditional Chinese and Western Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed