A Multicenter, Randomized, Controlled Clinical Trial of Jinghua Weikang Capsule for Maintenance Treatment of Reflux Esophagitis
jinghua weikang capsule
Digestive System Diseases+7
+ Duodenal Diseases
+ Esophageal Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.260 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives