Reflux esophagitis
Conditions
Interventions
Control group:Patients who met the inclusion criteria and were not excluded were randomly divided into test group and control group. Control group (Group B) : Ganhaiweikang capsule simulation agent co
Rabeprazole sodium enteric-coated capsule 20mg/ time qd. The drug was administered for 8 weeks.
Experimental group:Patients who met the inclusion criteria and were not excluded were randomly divided into test group and control group. Experimental group (group A) : Ganhaiweikang capsule combined
Rabeprazole sodium enteric-coated capsule 20mg/ time qd. 8 weeks of medication
Sponsors
TIANJIN HOSPITAL OF ITCWM NANKAI HOSPITAL
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The patient was diagnosed with RE (reflux esophagitis) by gastroscopy (valid within one month) and met the GERD grade A and B diagnostic criteria for reflux esophagitis (Los Angeles Grading System); 2. Age 18-65 years old (including boundary value) gender is not limited; 3. TCM syndrome differentiation is consistent with the symptoms of spleen deficiency qi stagnation and middle deficiency qi inversion; 4. Weekly mean value of reflux or heartburn VAS score =3.0; 5. Gastroesophageal reflux disease questionnaire (Gerd Q) score =8 points; 6. No drugs that affect mucosal healing have been used since the gastroscopy report and no history of gastrointestinal motonics traditional Chinese medicine and other related treatment in the past week; 7. No other systemic acute or chronic infection; 8. Voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with drug-induced esophagitis immune-related esophageal lesions upper gastrointestinal ulcers esophageal tumors and other diseases with similar symptoms; 2. Have previously undergone surgery that may affect esophageal or gastric function or gastric acid secretion or plan to undergo surgical procedures during the study period that may affect esophageal and gastric motility or gastric acid secretion; 3. Patients with previous rheumatic immune diseases that may affect esophageal motility such as scleroderma and Behcet's disease; Or have a history of esophageal radiotherapy or esophageal cryotherapy; 4. Those who have previously been diagnosed with organic diseases of the digestive system such as achalasia of the cardia syndrome inflammatory bowel disease intestinal tuberculosis intestinal ulcer acute and chronic pancreatitis cirrhosis gallstones with cholecystitis in the acute stage other digestive system tumors or those who have had peptic ulcer in the past 3 months; 5. Helicobacter pylori positive (all tests are valid within six months); 6. Previous diagnosis of other systemic diseases affecting digestive tract function such as hyperthyroidism or hypothyroidism chronic renal insufficiency autoimmune diseases diabetes etc.; 7. Patients with a history of serious diseases of the heart brain liver kidney immune hematopoietic and other systems as well as tumors neurological or psychiatric diseases (such as major depression/anxiety/bipolar disorder); 8. Concomitant drugs that affect gastrointestinal motility and function should not be discontinued during the trial such as acid suppressors antacids kinetotropic drugs anticholinergics calcium channel blockers (except antihypertensive drugs) 5-HT3 receptor antagonists antidepressants antianxiety drugs etc.; 9. Pregnant or lactating women patients who had a birth plan from enrollment to 1 month after the end of the trial; 10. Allergic to the test drug and its ingredients; 11. Suspect or have a history of alcohol or drug abuse; 12. Patients who participated in other clinical trials within 1 month prior to enrollment; Other subjects considered inappropriate for clinical trials such as those with serious illness requiring emergency treatment or those with insufficient compliance could not complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endoscopic recovery of esophageal mucosa; | — |
Secondary
| Measure | Time frame |
|---|---|
| Degree of depression;Reflux or heartburn pain score;Gastroesophageal reflux disease score;Anxiety level;TCM clinical symptoms and efficacy scores; | — |
Countries
China
Contacts
Public ContactTang Yanping
TIANJIN HOSPITAL OF ITCWM NANKAI HOSPITAL
Outcome results
None listed