Clinical Trial for efficacy, safety and economic evalation of Wolbigachul-tang for chronic cough due to upper airway cough syndrome (UACS)
- Conditions
- Diseases of the respiratory system
- Registration Number
- KCT0007822
- Lead Sponsor
- Daejeon Korean Medicine Hospital of Daejeon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 30
1. Chronic cough patients for more than 8 weeks, aged 19–75 years
2. Experienced sensation of ‘mucus in the throat' including conditions as rhinorrhea, throat discomfort, itching, foreign body sensation or observed pebble-like changes in posterior pharyngeal wall or has findings indicating sinusitis on PNS X-ray
3. Daytime Cough Symptom Score = 2 points, Night-time Cough Symptom Score = 1 point
4. Patients who consent to participate
1. Those with abnormal findings that could cause cough as a result of chest x-ray
2. Those with abnormal findings in lung function tests (FEV <80% predicted or FEV1/FVC <70%)
3. Those who have been diagnosed with acute respiratory disease including upper respiratory tract within the last 1 month
4. Those who have been diagnosed with chronic respiratory diseases (chronic obstructive pulmonary disease, bronchial asthma, bronchiectasis, interstitial pulmonary disease and other chronic respiratory diseases) within the last 2 years
5. Those who have been diagnosed gastroesophageal reflux disease within the last 1 year
6. Those who have been taking steroids, anti-leukotrienes, anticholinergics, long-acting ß2 agonists, antihistamines, antitussive, and expectorant within the last 2 weeks
7. Those who have taken proton pump inhibitors, histamine receptor antagonists, mucosal protective agents, gastrointestinal motility promoters, antacids, antidepressants, anxiolytics, and lower esophageal sphincter agonists for the treatment of gastroesophageal reflux disease symptoms within the last 2 weeks
8. Those who have been taking or have taken an angiotensin-converting-enzyme inhibitor within the last 4 months
9. Liver or renal impairment (alanine aminotransferase(ALT), aspartate aminotransferase(AST), alkaline phosphatase(ALP), creatinine = 2 times the normal upper limit, at screening)
10. Genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
11. Comorbidities that may interrupt the treatment of cancers or clinical significant disorders of the kidney, liver, psychiatric system, cardiovascular system, respiratory system, endocrine system, and central nervous system, the safety assessment, or completion of this clinical study
12. Unregulated hypertension (systolic blood pressure = 160 mmHg or diastolic blood pressure =100 mmHg in the relaxation period)
13. Unregulated diabetes (fasting blood glucose = 180 mg/dL)
14. Allergy or sensitizer to test drug / comparator
15. History of alcoholism or substance abuse
16. Current smoker or history or smokr more than 30 years
17. Pregnant or breast-feeding
18. Those who did not consent to contraception during the clinical trial
19. Participation in other clinical drug(medicine) trials during the last 30 days before study inclusion
20. Judged by the investigators to be inappropriate for the clinical trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cough Symptom Score (CSS)
- Secondary Outcome Measures
Name Time Method Cough VAS;Nasal Discharge Score;Questionnaire of Clinical Symptoms of Cough and Sputum;Leicester Cough Questionnaire - Korean Verstion (LCQ-K) ;Integrative Medicine Outcome Scale (IMOS);Integrative Medicine Patient Satisfaction Scale (IMPSS);5-level EuroQol 5-dimensional questionnaire (EQ-5D-5L)