Refractory Gastroesophageal Reflux Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Western medicine diagnoses match rGERD; (2) Traditional Chinese medicine identifies it as Liver Stomach Stasis Heat Type Syndrome; (3) Participants must be between 18 and 75 years old; (4) Individuals must voluntarily participate and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients who have previously taken a double dose of Rabeprazole for eight weeks. (2) Recent history of medication use affecting the gastrointestinal tract such as glucocorticoids aspirin and calcium channel blockers. (3) Individuals with organic upper gastrointestinal diseases such as gastric ulcers or gastric cancer and those with primary esophageal motility disorders. (4) Patients with severe primary diseases affecting other systems. (5) Individuals with a history of surgeries in the gastroesophageal region. (6) Pregnant or breastfeeding women and individuals with legally defined disabilities (such as blindness deafness mutism intellectual disabilities or mental disorders). (7) Participants with allergies intolerances or contraindications related to the medication involved in this trial. (8) Patients concurrently enrolled in other drug clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Utilize the symptom section A (heartburn + reflux) total score of the GerdQ scale. ;Recurrence rates in half a year; | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-Rating Depression Scale(SDS);Traditional Chinese Medicine Symptom ClinRO Evaluation Scale;Pittsburgh Sleep Quality Index(PSQI);Analysis of Gut Microbiome Composition;Resting and residual pressure of the upper esophageal sphincter;Distal Latency (DL);Metabolomics;Reflux number;Mean nocturnal baseline impedance (MNBI);RDQ Scale;Serum VIP;Resting and residual pressure of the lower esophageal sphincter;Distal contractile integral (DCI);Self-Rating Anxiety Scale (SAS);Esophagogastric junction-contractile integral(EGJ-CI);Integrated relaxation pressure (IRP);Serum Gastrin;Serum 5-hydroxytryptamine(5-HT);Acid exposure time (AET);Post-reflux swallow-induced peristaltic wave (PSPW); | — |
Countries
China
Contacts
Fangshan Hosptial of Beijing University of Chinese Medicine