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

Launched by TONGJI HOSPITAL · May 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a herbal medicine called Jinsang Liyan capsules, used together with a common acid-reducing medication known as a PPI (specifically, rabeprazole), to see if this combination is more effective than the PPI alone in treating Laryngopharyngeal Reflux Disease (LPRD). LPRD is a condition where stomach contents flow back into the throat, causing symptoms like a sore throat, cough, or a feeling of something stuck in the throat. Participants in the study will be randomly divided into two groups: one group will receive the Jinsang Liyan capsules along with the PPI, while the other group will get a placebo (a sugar pill that looks like the real medication) with the PPI. Researchers will follow up with participants at 4 and 8 weeks to see how well their symptoms improve.

To be eligible for this trial, participants must be between 18 and 65 years old and have been diagnosed with LPRD. They should not have taken any antacids or certain gastrointestinal medications in the two weeks before joining the study. Some individuals, such as those with serious other health issues or specific digestive system conditions, will not be able to participate. If you join the trial, you can expect to take the medication as directed and attend follow-up visits to discuss your progress. Your participation will help researchers determine if this new treatment is more beneficial for people with LPRD.

Gender

ALL

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.