Comparative study of improving quality of sleep according to the method of ilaprazole administration for the treatment of Laryngopharyngeal reflux disease
- Conditions
- Diseases of the respiratory system
- Registration Number
- KCT0003450
- Lead Sponsor
- Kunkuk University Chungju Hospital
- Brief Summary
In this study, 100 subjects were divided into a group administered with ilaprazole 10mg twice a day (Bid group) and a group administered with ilaprazole 20mg once a day (QD group) from May 20, 2018 to May 30, 2021, and administered for 8 weeks. After that, the treatment rate according to the administration method was evaluated. According to the RSI and RFS tests performed on the start and end dates of the study, the treatment effect was high in the ilaprazole 10 mg twice a day group. It was confirmed that the group administered with 10 mg twice a day was more effective in improving symptoms than the group administered with 20 mg once a day. Regardless of the administration method, it was confirmed in the survey that the quality of sleep improved along with symptom improvement after taking the drug. During the study period, no adverse reactions or side effects occurred after taking the drug . Therefore, if you have symptoms such as chronic pharyngeal foreign body sensation, voice change, hoarseness, and cough due to pharyngeal reflux, it would be better to administer 10 mg twice for a day rather than 20 mg once a day.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Patients whose RSI and RFS values are above 14 and 8, and diagnosed with Laryngopharyngeal reflux disease by laryngeal endoscopic finding.
-Those who are sensitive to Proton Pump Inhibitor (PPI)
-Those who have taken anti reflux medication, Prokinetics or H2-blocker within one month.
-Those who had history of malignant tumor of larynx
-Those who need to continuously take Warfarin, Coumarin, Non-steroidal anti inflammatory drugs including Aspirin (above 325mg/d) or Steroid medication during clinical trial.
- Those who have undergone gastric acid suppression surgery or gastric or duodenal surgery.
- Those who have undergone major surgery that may affect gastric acid secretion, except surgery such as appendectomy, cholecystotomy and hysterectomy.
- Those with Zollinger-Ellison syndrome and alcoholics, or those with a history of current drug abuse.
- Those using a CPAP(Continuous Positive Airway Pressure) for treating sleep apnea symptoms.
- Pregnant and lactating women.
- A woman of childbearing expected to be pregnant (Menopausal women who are more than at least 12 months of age are considered non-childbearing women)
- Those whe had participated in other clinical trial within 30 days before screening.
- Those who are considered not suitable for this study by researcher.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reflux Symptom Index (RSI);Reflux Finding Score (RFS)
- Secondary Outcome Measures
Name Time Method Functional Outcomes of Sleep Questionnaire (FOSQ-10);Pittsburg Sleep Quality Index (PSQI)