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Jinghua Weikang Capsule in the Treatment of Reflux Esophagitis

Primary Purpose

Reflux Esophagitis

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
jinghua weikang capsule
Sponsored by
The First Affiliated Hospital of Dalian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reflux Esophagitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Trials group

    Control group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Reduce the recurrence rate of R reflux esophagitis and relieve symptoms
    To explore the clinical effect of Jinghua Weikang Capsule on the maintenance treatment of reflux esophagitis, in order to reduce the recurrence rate of reflux esophagitis and relieve symptoms.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 18, 2023
    Last Updated
    September 25, 2023
    Sponsor
    The First Affiliated Hospital of Dalian Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06056973
    Brief Title
    Jinghua Weikang Capsule in the Treatment of Reflux Esophagitis
    Official Title
    A Multicenter, Randomized, Controlled Clinical Trial of Jinghua Weikang Capsule for Maintenance Treatment of Reflux Esophagitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2025 (Anticipated)
    Study Completion Date
    October 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The First Affiliated Hospital of Dalian Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Reflux Esophagitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    260 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Trials group
    Arm Type
    Experimental
    Arm Description
    PPI treatment for 8 weeks, ( d1-d56 ), Jinghua weikang capsules 2 tid, 28 days of treatment.
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Control group ( 130 cases ) : PPI treatment for 8 weeks, ( d1-d56 ), PPI treatment for 28 days.
    Intervention Type
    Drug
    Intervention Name(s)
    jinghua weikang capsule
    Intervention Description
    Oral Jinghua Weikang Capsule, two capsules each time, three times a day
    Primary Outcome Measure Information:
    Title
    Reduce the recurrence rate of R reflux esophagitis and relieve symptoms
    Description
    To explore the clinical effect of Jinghua Weikang Capsule on the maintenance treatment of reflux esophagitis, in order to reduce the recurrence rate of reflux esophagitis and relieve symptoms.
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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: 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.

    12. IPD Sharing Statement

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    Jinghua Weikang Capsule in the Treatment of Reflux Esophagitis

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