Effectiveness and safety of Maekmoondong-tang for chronic dry cough

Not Applicable

Recruiting

• Conditions: Diseases of th respiratory system

• Registration Number: KCT0001646
• Lead Sponsor: Kyung Hee University Oriental Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 58

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

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.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The mean difference of the cough diary scores at 28 days between Maekmoondong-tang(MMDT) treatment group and the placebo group.

Secondary Outcome Measures

Name	Time	Method
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.