Reflux EsophagitisPhase 4NCT06056973
Jinghua Weikang Capsule in the Treatment of Reflux Esophagitis
A Phase 4 study testing jinghua weikang capsule in people with Reflux Esophagitis, run by The First Affiliated Hospital of Dalian Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Reflux Esophagitis
- What is being tested?
- jinghua weikang capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 ;
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- 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.
About this study
Official title: A Multicenter, Randomized, Controlled Clinical Trial of Jinghua Weikang Capsule for Maintenance Treatment of Reflux Esophagitis
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.
- Conditions
- Reflux Esophagitis
- Being tested
- jinghua weikang capsule
- Medical subject headings
- Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
jinghua weikang capsuleDrug
Oral Jinghua Weikang Capsule, two capsules each time, three times a day
| Study group | Role | What they receive |
|---|---|---|
| Trials group | Experimental | PPI treatment for 8 weeks, ( d1-d56 ), Jinghua weikang capsules 2 tid, 28 days of treatment. Receives: Drug: jinghua weikang capsule |
| Control group | Active comparator | Control group ( 130 cases ) : PPI treatment for 8 weeks, ( d1-d56 ), PPI treatment for 28 days. Receives: Drug: jinghua weikang capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reflux EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhijun Duan, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056973
- Sponsor's protocol ID
- PJ-KS-KY-2023-337(X)
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Clinical Trial of Jinghua Weikang Capsule for Maintenance Treatment of Reflux Esophagitis
- ClinicalTrials.gov ID
- NCT06056973
- Acronym / sponsor ID
- PJ-KS-KY-2023-337(X)
- Conditions
- Reflux Esophagitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trials group | Experimental | Drug: jinghua weikang capsulePPI treatment for 8 weeks, ( d1-d56 ), Jinghua weikang capsules 2 tid, 28 days of treatment. |
| Control group | Active comparator | Drug: jinghua weikang capsuleControl group ( 130 cases ) : PPI treatment for 8 weeks, ( d1-d56 ), PPI treatment for 28 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| jinghua weikang capsuleOral Jinghua Weikang Capsule, two capsules each time, three times a day | Drug | Control group, Trials group |
Primary outcome
Reduce the recurrence rate of R reflux esophagitis and relieve symptoms
Time frame: 9 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing jinghua weikang capsule in people with Reflux Esophagitis, run by The First Affiliated Hospital of Dalian Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduce the recurrence rate of R reflux esophagitis and relieve symptoms (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.