Refractory Gastroesophageal Reflux Disease
Conditions
Interventions
Experimental Group:Shugan Hewei Granules (10g/bag), take 1 bag each time, twice daily, 30 minutes after breakfast and dinner
Esomeprazole Enteric-coated Capsule Simulant (40mg/pill), take 1 pill each time, once daily, 1 hour before dinner. The course of treatment is 8 weeks for both.
Control Group:Esomeprazole magnesium enteric-coated capsules (40 mg per capsule), take 1 capsule once daily, 1 hour before dinner
liver-soothing and stomach-harmonizing granule simulator (10 g per sachet), take 1 sachet twice daily, 30 minutes after breakfast and dinner. The course of treatment is 8 weeks for both.
Sponsors
Shanghai University of Traditional Chinese Medicine Affiliated Yueyang Integrated Chinese and Western Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Meet the diagnostic criteria for liver-stomach disharmony syndrome of gastroesophageal reflux disease (GERD) in Traditional Chinese Medicine (TCM). 2) Meet the diagnostic criteria for GERD in Western medicine; Failed 8-week continuous double-dose PPI treatment prior to this study; 3) Reflux VAS score =4 and heartburn VAS score =4 (VAS scores based on weekly averages during lead-in period); 4) Aged =18 and =75 years, any gender.
Exclusion criteria
Exclusion criteria: 1. Patients presenting with "alarm symptoms" such as dysphagia, hematemesis, melena, or weight loss, or those already diagnosed with tumors; individuals with structural abnormalities of the digestive tract or other organic diseases that may cause reflux-related symptoms (e.g., hiatal hernia, achalasia, diabetic gastroparesis, eosinophilic esophagitis, etc.); patients with positive Helicobacter pylori (Hp) test results (C13- or C14-UBT). 2. Patients with concurrent primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, or hematological systems, or mental disorders (e.g., severe anxiety, severe depression). 3. Pregnant women (positive pregnancy test in women of childbearing age) or lactating women. 4. Patients who have taken or will need to take clopidogrel or other medications affecting the metabolism of the drug under investigation within the past 2 weeks or during the study period. 5. Patients who have used Chinese or Western medications related to the current condition within the past 2 weeks and are either not allowed by their condition or unwilling to undergo a 2-week drug washout period. 6. Patients currently participating in or having participated in other drug clinical trials within the past 4 weeks. 7. Patients with an allergy to the drug under investigation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate of Reflux/Heartburn VAS Scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| The response efficacy of Visual Analogue Scale (VAS) scores for retrosternal pain symptoms.;GERD-Q (Gastroesophageal Reflux Disease Questionnaire) Assessment Status;Changes in TCM Symptom Scores and Efficacy;Changes in 24-hour pH/Impedance Monitoring Parameters (Demeester Score, Acid Exposure Time (AET), Symptom Index (SI), Symptom Association Probability (SAP)) After 8-week Treatment;Hospital Anxiety and Depression Scale (HAD) Scores;GERD-HRQL Scale Scores; | — |
Countries
China
Contacts
Public ContactFang Shengquan
Shanghai University of Traditional Chinese Medicine Affiliated Yueyang Integrated Chinese and Western Medicine Hospital
Outcome results
None listed