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A Multicenter, Randomized, Controlled Clinical Trial of Jinghua Weikang Capsule for Maintenance Treatment of Reflux Esophagitis

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What is being tested

jinghua weikang capsule

Drug
Who is being recruted

Digestive System Diseases+7

+ Duodenal Diseases

+ Esophageal Diseases

From 18 to 70 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: October 2023
See protocol details

Summary

Principal SponsorThe First Affiliated Hospital of Dalian Medical University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2023

Actual date on which the first participant was enrolled.

This clinical trial focuses on exploring the effectiveness of Jinghua Weikang capsules as a maintenance treatment for reflux esophagitis. Reflux esophagitis is a condition where stomach acid frequently flows back into the tube connecting the mouth and stomach, causing irritation. Typically, medications like proton pump inhibitors (PPIs) or potassium competitive acid blockers (P-CAB) are used to manage this condition. However, some patients continue to experience symptoms or severe forms of the disease even after long-term use of these medications. This study is important as it seeks to find alternative ways to manage and reduce the recurrence of symptoms, potentially offering a complementary treatment option that could enhance patient care and address unmet needs in managing this condition. In the trial, participants will receive Jinghua Weikang capsules, which are believed to help regulate and relieve symptoms associated with reflux esophagitis. The treatment is administered orally, aiming to provide relief from symptoms such as pain, belching, and acid reflux. Researchers will monitor the participants to evaluate the effectiveness of the capsules in reducing the recurrence of reflux episodes and alleviating symptoms. This study also examines how well Jinghua Weikang capsules work alongside conventional Western medicines, aiming to provide additional benefits without the long-term risks associated with current acid suppression therapies.

Official TitleA Multicenter, Randomized, Controlled Clinical Trial of Jinghua Weikang Capsule for Maintenance Treatment of Reflux Esophagitis
NCT06056973
Principal SponsorThe First Affiliated Hospital of Dalian Medical University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

260 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDuodenal DiseasesEsophageal DiseasesEsophagitisEsophagitis, PepticGastroenteritisGastrointestinal DiseasesIntestinal DiseasesPeptic UlcerStomach Diseases

Criteria

8 inclusion criteria required to participate
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 ;

Show More Criteria

9 exclusion criteria prevent from participating
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 ;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Control group ( 130 cases ) : PPI treatment for 8 weeks, ( d1-d56 ), PPI treatment for 28 days.

Group II

Experimental
PPI treatment for 8 weeks, ( d1-d56 ), Jinghua weikang capsules 2 tid, 28 days of treatment.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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