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A multicenter, randomized, controlled clinical trial of Jinghua Weikang capsule for maintenance treatment of reflux esophagitis

A multicenter, randomized, controlled clinical trial of Jinghua Weikang capsule for maintenance treatment of reflux esophagitis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080713
Enrollment
Unknown
Registered
2024-02-05
Start date
2024-02-15
Completion date
Unknown
Last updated
2024-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

reflux esophagitis

Interventions

test Group:Jinghua Weikang capsule

Sponsors

Tasly Pharmaceutical Group Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: ·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 criteria

Exclusion criteria: ·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.

Design outcomes

Primary

MeasureTime frame
Recurrence rate;

Secondary

MeasureTime frame
Time to recurrence;Symptoms of recurrence;safety index;

Countries

China

Contacts

Public ContactZhijun Duan

The First Afiliated Hospital of Dalian Medical University

cathydoctor@sina.com+86 180 9887 5588

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026