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Clinical Study of Jinsang Liyan Capsules Combined With PPI in the Treatment of LPRD

Primary Purpose

Laryngopharyngeal Reflux

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Jinsang Liyan Capsule; Rabeprazole enteric-coated tablets.
Jinsang Liyan Capsule placebo; Rabeprazole enteric-coated tablets.
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laryngopharyngeal Reflux focused on measuring Laryngopharyngeal Reflux, proton pump inhibitors, Jinsangliyan capsule, treatment, therapeutic evaluation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    experimental group

    control group

    Arm Description

    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;

    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;

    Outcomes

    Primary Outcome Measures

    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%

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    May 8, 2023
    Last Updated
    May 26, 2023
    Sponsor
    Tongji Hospital
    Collaborators
    Xi'an Beilin Pharmaceutical Co. Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05879029
    Brief Title
    Clinical Study of Jinsang Liyan Capsules Combined With PPI in the Treatment of LPRD
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tongji Hospital
    Collaborators
    Xi'an Beilin Pharmaceutical Co. Ltd

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Laryngopharyngeal Reflux
    Keywords
    Laryngopharyngeal Reflux, proton pump inhibitors, Jinsangliyan capsule, treatment, therapeutic evaluation

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    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;
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Arm Description
    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;
    Intervention Type
    Drug
    Intervention Name(s)
    Jinsang Liyan Capsule; Rabeprazole enteric-coated tablets.
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Jinsang Liyan Capsule placebo; Rabeprazole enteric-coated tablets.
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    total effective rate
    Description
    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%
    Time Frame
    2 months
    Secondary Outcome Measure Information:
    Title
    RFS(reflux finding score)
    Description
    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.
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiang Lu, professor
    Phone
    027-83662691
    Email
    luxiangent@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xiang Lu, professor
    Organizational Affiliation
    Tongji Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Study of Jinsang Liyan Capsules Combined With PPI in the Treatment of LPRD

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