Effectiveness and safety of Maekmoondong-tang for chronic dry cough– a Exploratory, single-center, placebo-controlled, double-blind, randomized, parallel clinical trial

Kyung Hee University Oriental Medical Center0 个研究点目标入组 58 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•1. Adults between 19 and 75 years
•2. Chronic cough lasting more than 8 weeks
•3. Dry cough (= 5 times a day in Sputum frequency and = 10ml a day in Sputum amounts , Sputum Severity Evaluation Standard by Korean Ministry of Food and Drug Safety)
•4. Patients wrote in informed consent form

•1. Abnormal pulmonary forced test (Forced Expiratory Volume in 1 sec(FEV1.0) < 80% predicted or Forced Vital Capacity (FVC) < 80% predicted)
•2. Abnormal chest x-ray
•3. Previous acute respiratory diseases includes upper respiratory infection within 4 weeks
•4. Chronic pulmonary diseases (Chronic Obstructive Pulmonary Disease(COPD), Bronchiectasis, Idiopathic Pulmonary Fibrosis(IPF), lung cancer) within 2 years.
•5. Diagnosis of malignant tumor within 5 years.
•6. Patients with a history of smoking 20 packs (400 cigarettes) during life.
•7. Medication with angiotensin-converting-enzyme inhibitor or a history of medication within 4 months.
•8. Medication with antitussive drugs, glucocorticoids, leukotriene receptor antagonists, anticholinergic drugs, long-acting ß 2 agonist or herbal medicine within 2 weeks of enrollment in the study
•9. Medication with an antihistamine within 3 days
•10. Patients with the level of ASpartate Transaminase(AST). ALanine Transaminase(ALT) 2 times higher than the upper limit of normal, abnormal serum creatinine level, 1.2 times higher than upper limit of normal.
•11.The mean value of cough diary is less than 2 within the run-in-period (7 days)
•12. Patients with filling in cough diary less than 10 times within the run-in-period (7 days)
•13. Be in pregnant or feeding
•14. Not possible to writing and reading or having cognitive impairment
•15. Inadequate participants by investigator's judgement.

发起方

Kyung Hee University Oriental Medical Center