Treatment of Laryngopharyngeal Reflux with Jinsang Liyan Capsules and PPI
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
This study is testing if taking Jinsang Liyan capsules along with a common heartburn medication can help people with Laryngopharyngeal Reflux feel better compared to just the medication alone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05879029 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Jinsang Liyan capsules in combination with proton pump inhibitors (PPI) compared to PPI alone for treating Laryngopharyngeal Reflux Disease (LPRD). Participants will be randomly assigned to receive either the Jinsang Liyan capsule with rabeprazole or a placebo with rabeprazole. The study will assess symptom improvement at 4 and 8 weeks post-treatment. The goal is to determine if the combination therapy provides superior relief from LPRD symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 diagnosed with LPRD who have not taken antacids or gastrointestinal motility drugs in the two weeks prior to enrollment.
Not a fit: Patients with severe digestive system diseases or acute upper respiratory infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer improved symptom relief for patients suffering from LPRD.
How similar studies have performed: Previous studies have shown positive outcomes with similar treatments for LPRD, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wuhan, Hubei
- Department of Otolaryngology-Head and Neck Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Xiang Lu, professor — Tongji Hospital
- Study coordinator: Xiang Lu, professor
- Email: luxiangent@hotmail.com
- Phone: 027-83662691
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.