NCT05879029

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Laryngopharyngeal Reflux

Interventions

Type	Name	Description
DRUG	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	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.

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-05-30
• Last updated: 2024-01-23

Locations

1 site across 1 country: China