KCT0007822尚未招募未知
Efficacy, safety and economic evaluation of Wolbigachul-tang for chronic cough due to upper airway cough syndrome (UACS): a randomized, double-blind, active-comparator controlled, parallel, exploratory clinical trial
Daejeon Korean Medicine Hospital of Daejeon University0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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