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

NCT05879029 | Unknown Phase 4

• 1 other identifier: TJ-IRB20230353
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Laryngopharyngeal Reflux; proton pump inhibitors; Jinsangliyan capsule; treatment; therapeutic evaluation

Outcome Measures

Primary Outcomes (1)

• total effective rate

  Visual analogue scale (VAS) is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. Reflux Symptom Index (RSI) is a questionnaire that measures the severity of symptoms associated with laryngopharyngeal reflux (LPR). Symptom improvement rate = (VAS score before treatment - VAS score after treatment)/VAS score before treatment ×100% Obvious: Symptom improvement rate ≥80%; Or RSI≤13 points. Effective: 50% ≤ Symptom improvement rate \<80%; Or RSI decreased, but still \>13 points. Ineffective: Symptom improvement rate \<50%; Or no reduction in RSI. Total effective rate =\[(obvious + effective)/total cases\]×100%

  2 months

Secondary Outcomes (1)

• RFS(reflux finding score)

  2 months

Study Arms (2)

experimental group

EXPERIMENTAL

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;

Drug: Jinsang Liyan Capsule; Rabeprazole enteric-coated tablets.

control group

PLACEBO COMPARATOR

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;

Drug: Jinsang Liyan Capsule placebo; Rabeprazole enteric-coated tablets.

Interventions

Jinsang Liyan Capsule; Rabeprazole enteric-coated tablets. DRUG

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.

experimental group

Jinsang Liyan Capsule placebo; Rabeprazole enteric-coated tablets. DRUG

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.

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead
• Xi'an Beilin Pharmaceutical Co. Ltd: collaborator

Study Sites (1)

Department of Otolaryngology-Head and Neck Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Laryngopharyngeal Reflux

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases

Study Officials

• Xiang Lu, professor

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang Lu, professor

CONTACT

027-83662691; luxiangent@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 30, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

CN (1)