Jinghua Weikang Capsule in the Treatment of Reflux Esophagitis (NCT06056973) | Clinical Trial Compass
UnknownPhase 4
Jinghua Weikang Capsule in the Treatment of Reflux Esophagitis
260 participantsStarted 2023-10-01
Plain-language 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 symptoms and severe esophagitis ( Los Angeles grade C and D ) after long-term use of PPI or P-CAB usually need long-term maintenance treatment. Attention should be paid to the possible adverse reactions of long-term acid suppression therapy and the interaction between drugs. The main efficacy of Jinghua Weikang capsules is regulating qi and dispersing cold, clearing heat and removing blood stasis. Applicable to cold and heat syndrome, qi stagnation and blood stasis caused by epigastric distension, pain, belching, acid reflux, noisy, bitter taste ; duodenal ulcer see the above syndrome. In the early stage, a series of studies were carried out on Jinghua Weikang Capsule, which confirmed that Jinghua Weikang Capsule showed the effect of acid inhibition and symptom relief in the treatment of reflux esophagitis, and had a synergistic effect when combined with western medicine. However, Jinghua Weikang Capsule still lacks sufficient evidence to support the reduction of the recurrence rate of reflux esophagitis. Therefore, we carried out this experiment to explore the clinical efficacy of Jinghua Weikang Capsule in the maintenance treatment of reflux esophagitis, so as to reduce the recurrence rate of reflux esophagitis and relieve symptoms.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* 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 particip…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduce the recurrence rate of R reflux esophagitis and relieve symptoms
Timeframe: 9 months
Trial details
NCT IDNCT06056973
SponsorThe First Affiliated Hospital of Dalian Medical University