Laryngopharyngeal RefluxPhase 4NCT05879029
Clinical Study of Jinsang Liyan Capsules Combined With PPI in the Treatment of LPRD
A Phase 4 study testing Jinsang Liyan Capsule; Rabeprazole enteric-coated tablets. in people with Laryngopharyngeal Reflux, run by Tongji Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the efficacy of Jinsang Liyan capsule in combination with PPI versus PPI alone for the treatment of Laryngopharyngeal Reflux Disease (LPRD). Participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laryngopharyngeal Reflux
- What is being tested?
- Jinsang Liyan Capsule; Rabeprazole enteric-coated tablets.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to Dec 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients who met the clinical diagnostic criteria for LPRD (by asking history and laryngoscopy, RSI score >13 or RFS score >7 points);
- No antacids or gastrointestinal motility drugs were taken within 2 weeks before enrollment.
- Be aged 18-65 years with no gender restriction;
- Patients understood and agreed to participate in this study and signed an informed consent form.
Who cannot join
- complicated with acute upper respiratory tract infection;
- combined with one of the following diseases of the digestive system: peptic ulcer, history of gastroesophageal and duodenal surgery, Zollinger-Ellison syndrome, pyloric obstruction, primary esophageal motility disorders (e.g., achalasia, scleroderma, primary esophageal spasm), drug-induced esophagitis, mycotic esophagitis, gastrointestinal malignant tumor;
- patients with severe primary diseases of heart, brain, liver, lung, kidney, blood and endocrine system, and severe psychosis without effective control;
- those who could not take medicine during pregnancy or lactation, or who were allergic to the drugs used in this study; Or unable to cooperate with medication and complete relevant records due to various circumstances;
- patients who have participated or are participating in other drug clinical trials within three months;
- patients judged by the investigator to be ineligible for trial participation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Otolaryngology-Head and Neck Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Xiang Lu
Xiang Lu
About this study
Official title: Clinical Study of Jinsang Liyan Capsules Combined With Proton Pump Inhibitors in the Treatment of Laryngeal Reflux Disease (LPRD): a Randomized, Double-blind, Placebo-controlled Trial
The goal of this clinical trial is to compare the efficacy of Jinsang Liyan capsule in combination with PPI versus PPI alone for the treatment of Laryngopharyngeal Reflux Disease (LPRD).
Participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group. The experimental group was treated with Jinsangliyan capsule + rabeprazole enteric-coated tablets, and the control group was treated with Jinsangliyan capsule placebo + rabeprazole enteric-coated tablets. Participants were followed up at 4 weeks and 8 weeks after taking the drug to evaluate the improvement of LPRD symptoms.
Researchers will compare Experimental group and control group to see if Jinsang Liyan capsule combined with PPI treatment is superior to PPI treatment alone.
Read the detailed description
According to Expert Consensus on the Diagnosis and Treatment of Throat reflux Diseases (2022, Revised edition) [J], proton pump inhibitors are the preferred drug for the medical treatment of LPRD, which can not only protect the mucosa of the upper respiratory tract and digestive tract from gastric acid damage, but also reduce the damage caused by pepsin.
At present, PPI is still the first choice for the treatment of LPRD. Other drugs include H2 blockers, gastrointestinal motonics, gastric mucosa protectors, etc. These treatments mostly focus on the response to the main pathogenic factor of stomach acid, while ignoring the symptomatic treatment of the local discomfort in the throat of LPRD patients. As a result, there are some problems in clinical treatment, such as long course of treatment, easy recurrence, easy to appear adverse reactions, poor patient compliance, etc., and it is difficult to achieve the ideal effect. Therefore, to alleviate the suffering of patients with LPRD, there is an urgent need to develop new and more effective treatments for the disease.
Many literatures have been published on the treatment of LPRD by Jinshuoliyan Pill. These studies show that Jinshuoliyan Pill has a good effect in the adjuvant treatment of laryngeal reflux disease, can significantly reduce reflux symptoms and reduce the damage to the esophageal and throat mucosa, and has certain clinical value.However, the effect of Jinsang Liyan Capsule combined with PPI in the treatment of LPRD has not been confirmed by research.
The goal of this clinical trial is to compare the efficacy of Jinsang Liyan capsule in combination with PPI versus PPI alone for the treatment of Laryngopharyngeal Reflux Disease (LPRD).
Participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group. The experimental group was treated with Jinsangliyan capsule + rabeprazole enteric-coated tablets, and the control group was treated with Jinsangliyan capsule placebo + rabeprazole enteric-coated tablets. Participants were followed up at 4 weeks and 8 weeks after taking the drug to evaluate the improvement of LPRD symptoms.
Researchers will compare Experimental group and control group to see if Jinsang Liyan capsule combined with PPI treatment is superior to PPI treatment alone.
- Conditions
- Laryngopharyngeal Reflux
- Being tested
- Jinsang Liyan Capsule; Rabeprazole enteric-coated tablets., Jinsang Liyan Capsule placebo; Rabeprazole enteric-coated tablets.
- Keywords
- Laryngopharyngeal Reflux, proton pump inhibitors, Jinsangliyan capsule, treatment, therapeutic evaluation
- Medical subject headings
- Laryngopharyngeal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jinsang Liyan Capsule; Rabeprazole enteric-coated tablets.Drug
Participants in the experimental group were given Jinsang Liyan Capsule + Rabeprazole enteric-coated tablets according to the requirements, and were followed up at 4 and 8 weeks. VAS and RSI scores were used to judge the improvement degree of patients' symptoms.
Jinsang Liyan Capsule placebo; Rabeprazole enteric-coated tablets.Drug
Participants in the control group were given Jinsang Liyan Capsule placebo + Rabeprazole enteric-coated tablets according to the requirements, and were followed up at 4 and 8 weeks. VAS and RSI scores were used to judge the improvement degree of patients' symptoms.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Jinsang Liyan Capsule: oral, 0.4g/ capsule, 4 capsules, twice a day, for 8 weeks; Rabeprazole enteric-coated tablets: taken orally before breakfast, 10mg/ tablet, 2 tablets at a time, once a day, for 8 weeks; Receives: Drug: Jinsang Liyan Capsule; Rabeprazole enteric-coated tablets. |
| control group | Placebo comparator | Jinsang Liyan Capsule placebo: oral, 0.4g/ capsule, 4 capsules, twice a day, for 8 weeks; Rabeprazole enteric-coated tablets: taken orally before breakfast, 10mg/ tablet, 2 tablets at a time, once a day, for 8 weeks; Receives: Drug: Jinsang Liyan Capsule placebo; Rabeprazole enteric-coated tablets. |
What is being measured
The primary outcome is the main question the study is designed to answer.
total effective rate
Visual analogue scale (VAS) is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Reflux Symptom Index (RSI) is a questionnaire that measures the severity of symptoms associated with laryngopharyngeal reflux (LPR).
Symptom improvement rate = (VAS score before treatment - VAS score after treatment)/VAS score before treatment ×100%
Obvious: Symptom improvement rate ≥80%; Or RSI≤13 points.
Effective: 50% ≤ Symptom improvement rate <80%; Or RSI decreased, but still >13 points.
Ineffective: Symptom improvement rate <50%; Or no reduction in RSI.
Total effective rate =[(obvious + effective)/total cases]×100%
Measured: 2 months
Secondary outcomes (1)
RFS(reflux finding score)
RFS (reflux finding score) is a quantitative guide for diagnosis and treatment of laryngopharyngeal reflux. It is a score based on the presence and severity of various signs of reflux in the larynx and pharynx. The score ranges from 0 to 26, with higher scores indicating more severe reflux.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Jul 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngopharyngeal RefluxStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xi'an Beilin Pharmaceutical Co. Ltd
- Responsible party
- Principal investigator, Xiang Lu, Tongji Hospital
- Investigators
- Xiang Lu, professor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879029
- Sponsor's protocol ID
- TJ-IRB20230353
- Status last verified
- Jan 2024
- First submitted
- 8 May 2023
- Last updated
- 23 Jan 2024
- 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 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Jinsang Liyan Capsules Combined With Proton Pump Inhibitors in the Treatment of Laryngeal Reflux Disease (LPRD): a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05879029
- Acronym / sponsor ID
- TJ-IRB20230353
- Conditions
- Laryngopharyngeal Reflux
- Keywords
- Laryngopharyngeal Reflux, proton pump inhibitors, Jinsangliyan capsule, treatment, therapeutic evaluation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Xi'an Beilin Pharmaceutical Co. Ltd
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 30 May 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.
The goal of this clinical trial is to compare the efficacy of Jinsang Liyan capsule in combination with PPI versus PPI alone for the treatment of Laryngopharyngeal Reflux Disease (LPRD).
Participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group. The experimental group was treated with Jinsangliyan capsule + rabeprazole enteric-coated tablets, and the control group was treated with Jinsangliyan capsule placebo + rabeprazole enteric-coated tablets. Participants were followed up at 4 weeks and 8 weeks after taking the drug to evaluate the improvement of LPRD symptoms.
Researchers will compare Experimental group and control group to see if Jinsang Liyan capsule combined with PPI treatment is superior to PPI treatment alone.
Detailed description
According to Expert Consensus on the Diagnosis and Treatment of Throat reflux Diseases (2022, Revised edition) [J], proton pump inhibitors are the preferred drug for the medical treatment of LPRD, which can not only protect the mucosa of the upper respiratory tract and digestive tract from gastric acid damage, but also reduce the damage caused by pepsin.
At present, PPI is still the first choice for the treatment of LPRD. Other drugs include H2 blockers, gastrointestinal motonics, gastric mucosa protectors, etc. These treatments mostly focus on the response to the main pathogenic factor of stomach acid, while ignoring the symptomatic treatment of the local discomfort in the throat of LPRD patients. As a result, there are some problems in clinical treatment, such as long course of treatment, easy recurrence, easy to appear adverse reactions, poor patient compliance, etc., and it is difficult to achieve the ideal effect. Therefore, to alleviate the suffering of patients with LPRD, there is an urgent need to develop new and more effective treatments for the disease.
Many literatures have been published on the treatment of LPRD by Jinshuoliyan Pill. These studies show that Jinshuoliyan Pill has a good effect in the adjuvant treatment of laryngeal reflux disease, can significantly reduce reflux symptoms and reduce the damage to the esophageal and throat mucosa, and has certain clinical value.However, the effect of Jinsang Liyan Capsule combined with PPI in the treatment of LPRD has not been confirmed by research.
The goal of this clinical trial is to compare the efficacy of Jinsang Liyan capsule in combination with PPI versus PPI alone for the treatment of Laryngopharyngeal Reflux Disease (LPRD).
Participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group. The experimental group was treated with Jinsangliyan capsule + rabeprazole enteric-coated tablets, and the control group was treated with Jinsangliyan capsule placebo + rabeprazole enteric-coated tablets. Participants were followed up at 4 weeks and 8 weeks after taking the drug to evaluate the improvement of LPRD symptoms.
Researchers will compare Experimental group and control group to see if Jinsang Liyan capsule combined with PPI treatment is superior to PPI treatment alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Jinsang Liyan Capsule; Rabeprazole enteric-coated tablets.Jinsang Liyan Capsule: oral, 0.4g/ capsule, 4 capsules, twice a day, for 8 weeks; Rabeprazole enteric-coated tablets: taken orally before breakfast, 10mg/ tablet, 2 tablets at a time, once a day, for 8 weeks; |
| control group | Placebo comparator | Drug: Jinsang Liyan Capsule placebo; Rabeprazole enteric-coated tablets.Jinsang Liyan Capsule placebo: oral, 0.4g/ capsule, 4 capsules, twice a day, for 8 weeks; Rabeprazole enteric-coated tablets: taken orally before breakfast, 10mg/ tablet, 2 tablets at a time, once a day, for 8 weeks; |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patients who met the clinical diagnostic criteria for LPRD (by asking history and laryngoscopy, RSI score >13 or RFS score >7 points);
- No antacids or gastrointestinal motility drugs were taken within 2 weeks before enrollment.
- Be aged 18-65 years with no gender restriction;
- Patients understood and agreed to participate in this study and signed an informed consent form.
Key exclusion criteria (6 listed)
- complicated with acute upper respiratory tract infection;
- combined with one of the following diseases of the digestive system: peptic ulcer, history of gastroesophageal and duodenal surgery, Zollinger-Ellison syndrome, pyloric obstruction, primary esophageal motility disorders (e.g., achalasia, scleroderma, primary esophageal spasm), drug-induced esophagitis, mycotic esophagitis, gastrointestinal malignant tumor;
- patients with severe primary diseases of heart, brain, liver, lung, kidney, blood and endocrine system, and severe psychosis without effective control;
- those who could not take medicine during pregnancy or lactation, or who were allergic to the drugs used in this study; Or unable to cooperate with medication and complete relevant records due to various circumstances;
- patients who have participated or are participating in other drug clinical trials within three months;
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 |
|---|---|---|
| Jinsang Liyan Capsule; Rabeprazole enteric-coated tablets.Participants in the experimental group were given Jinsang Liyan Capsule + Rabeprazole enteric-coated tablets according to the requirements, and were followed up at 4 and 8 weeks. VAS and RSI scores were used to judge the improvement degree of patients' symptoms. | Drug | experimental group |
| Jinsang Liyan Capsule placebo; Rabeprazole enteric-coated tablets.Participants in the control group were given Jinsang Liyan Capsule placebo + Rabeprazole enteric-coated tablets according to the requirements, and were followed up at 4 and 8 weeks. VAS and RSI scores were used to judge the improvement degree of patients' symptoms. | Drug | control group |
Primary outcome
total effective rate
Time frame: 2 months
Visual analogue scale (VAS) is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. Reflux Symptom Index (RSI) is a questionnaire that measures the severity of symptoms associated with laryngopharyngeal reflux (LPR). Symptom improvement rate = (VAS score before treatment - VAS score after treatment)/VAS score before treatment ×100% Obvious: Symptom improvement rate ≥80%; Or RSI≤13 points. Effective: 50% ≤ Symptom improvement rate <80%; Or RSI decreased, but still >13 points. Ineffective: Symptom improvement rate <50%; Or no reduction in RSI. Total effective rate =[(obvious + effective)/total cases]×100%
1 secondary outcome
RFS(reflux finding score)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
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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.
Xiang Lu, professor principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Jinsang Liyan Capsule; Rabeprazole enteric-coated tablets. in people with Laryngopharyngeal Reflux, run by Tongji Hospital at 1 site in China.
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 4 inclusion and 6 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 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Xiang Lu, professor (027-83662691, luxiangent@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total effective rate (time frame: 2 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 23 Jan 2024.