Clinical Study of Jinsang Liyan Capsules Combined With PPI in the Treatment of LPRD
NCT05879029 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2024-01-23
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.
Conditions
- Laryngopharyngeal Reflux
Interventions
- 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.
Sponsors & Collaborators
-
Xi'an Beilin Pharmaceutical Co. Ltd
collaborator UNKNOWN -
Tongji Hospital
lead OTHER
Principal Investigators
-
Xiang Lu, professor · Tongji Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-01
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
Countries
- China
Study Locations
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