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: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Department of Otolaryngology-Head and Neck Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Xiang Lu, professor
luxiangent@hotmail.com
027-83662691
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2024-12
Participants
Target number of participants: 72
Treatments
Experimental: experimental group
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;
Placebo_comparator: control group
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;
Sponsors
Leads: Tongji Hospital
Collaborators: Xi'an Beilin Pharmaceutical Co. Ltd

This content was sourced from clinicaltrials.gov