Gastroesophageal Reflux Disease
Conditions
Interventions
experimental group:Jiang-Wei-An-Zhong Decoction twice daily + Rabeprazole as needed
control group:Simulated Jiang Wei An Zhong Decoction (5% Jiang Wei An Zhong Formula Granules + 95% Dextrin Twice daily)+Rabeprazole as needed
Sponsors
Fangshan Hosptial of Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Western medicine diagnoses match GERD; (2) Meets criteria for on-demand therapy, i.e., patients who experience recurrence after discontinuing initial 8-week acid suppression therapy and require on-demand maintenance treatment; (3) Diagnosed with Liver-Stomach Heat Pattern according to Traditional Chinese Medicine (TCM) syndrome differentiation; (4) Aged between 18 and 75 years; (5) Volunteers who participate and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Recent history of using medications affecting the gastrointestinal tract, such as corticosteroids, aspirin, calcium channel blockers, or 5-HT receptor antagonists; (2) Individuals who have undergone endoscopic examination to rule out organic lesions of the upper gastrointestinal tract (e.g., gastric ulcer, gastric cancer) or primary esophageal motility disorders; (3) Individuals with severe primary diseases in other systems; (4) History of surgery involving the gastroesophageal region; (5) Pregnant or lactating women; legally defined disabled individuals (blindness, deafness, muteness, intellectual disabilities, psychiatric disorders, etc.); (6) Allergies, intolerance, or contraindications to any drugs involved in this trial; (7) Patients concurrently participating in other drug clinical trials; (8) Patients concurrently taking other Chinese herbal medicines or traditional Chinese medicine formulations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the 1-month discontinuation rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total cumulative PPI dosage;GERD Primary Symptom Score;Recurrence rate;Esophageal motility-related indicators;Gastric-esophageal junction contraction integral;Resting pressure and residual pressure of the upper esophageal sphincter;Lower Esophageal Sphincter Resting Pressure and Residual Pressure;Integrated relaxation pressure;Distal Contractile Latency;Distal Contractile Integral ;24hpH-Impedance Monitoring Related Indicators;Acid Exposure Time;Number of Reflux Episodes;Post-reflux Swallow-induced Peristaltic Wave Index;Mean Nocturnal Baseline Impedance;Serum 5-HT;Serum VIP;Traditional Chinese Medicine Symptom ClinRO Evaluation Scale; | — |
Countries
China
Contacts
Public ContactCai Yanmei
Fangshan Hosptial of Beijing University of Chinese Medicine
Outcome results
None listed