Status:
UNKNOWN
Jinghua Weikang Capsule in the Treatment of Reflux Esophagitis
Lead Sponsor:
The First Affiliated Hospital of Dalian Medical University
Conditions:
Reflux Esophagitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Reflux esophagitis is a common clinical disease ; pPI or potassium competitive acid blocker ( P-CAB ) is the first choice for the treatment of reflux esophagitis. However, patients with recurrent symp...
Eligibility Criteria
Inclusion
- Sign informed consent.
- Men and women are not limited
- Age 18-70 years old
- Have been diagnosed as reflux esophagitis, and had recurrence after standard treatment ;
- Upper gastrointestinal endoscopy ( within 1 year ) had reflux esophagitis. In order to facilitate the observation of treatment time and effect, this project selected Los Angeles classification as reflux esophagitis A and B grade.
- GERD questionnaire reached 8 points in patients with
- Have appropriate organs and hematopoietic function, according to the following laboratory tests ( within 1 year ) Neutrophil count ( NEUT # ) ≥ 1.5 × 109 / L ; platelet count ≥ 75 × 109 / L ; hemoglobin ≥ 90g / L ; serum total bilirubin ( TBIL ) ≤ 2 times ULN ; alanine aminotransferase ( ALT ), aspartate aminotransferase ( AST ) ≤ 5 times ULN ; serum albumin ≥ 29 g / L ; serum creatinine ≤ 1.5 times the upper limit of normal ( ULN ) or creatinine clearance rate ≥ 50 mL / min.
- Normal electrocardiogram
Exclusion
- Patients who received antibiotics, bismuth, H2RA and PPI treatment within two weeks before the first medication ;
- pregnant or lactating women ;
- patients with moderate or above depression and mental disorders ;
- Patients with dysphagia and peptic ulcer such as achalasia, esophageal cancer ;
- patients with severe liver disease, heart disease, kidney disease, malignant tumor and alcohol dependence ;
- Those who are allergic to the drugs used in this study ;
- Patients who participated in other clinical studies within 3 months ;
- Patients who can not correctly express their complaints and have poor compliance ;
- There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, and subjects who the researchers believe are otherwise unfit to participate in the trial.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT06056973
Start Date
October 1 2023
End Date
October 1 2025
Last Update
September 28 2023
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