None listed
Conditions
Interventions
Drug : Arm 1
Maekmoondong-Tang / Maekgeuron Granule(Hanpoong Pharm & Food Co Ltd)
1 pouch/time, 3 times/day (before each meal)
3g/time, 9g/day
Oral administration
4 week treatment
Arm 2
The placebo wa
Sponsors
Kyung Hee University Oriental Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean difference of the cough diary scores at 28 days between Maekmoondong-tang(MMDT) treatment group and the placebo group. | — |
Secondary
| Measure | Time frame |
|---|---|
| The mean variation in cough vas analogue scale between treatment group and placebo group at 2 week, 4 week or 6 week. ;The mean difference of the Leicester Cough Questionnaire Korean version scores(LCQ-K) at 28 days between Maekmoondong-tang(MMDT) treatment group and the placebo group. ;Pattern type distribution in chronic dry cough patients using Pattern identification for chronic cough questionnaire(PICCQ) ;Pattern type distribution in chronic dry cough patients using Cold-Heat pattern questionnaire (C-H PQ) ;Pattern type distribution in chronic dry cough patients using Yin deficiency scale;The correlation between Maekmoondong-tang(MMDT) responder group/non-responder group and all patterns. ;Safety outcome(liver function test) and renal function test, Natrium(Na) and Potassium (K) ;The mean difference of the biomarker at 28 days between Maekmoondong-tang(MMDT) treatment group and the placebo group. | — |
Countries
Korea, Republic of
Contacts
Public ContactKwan-Il Kim
Kyung Hee University Oriental Medical Center
Outcome results
None listed