Study feasibility, preliminary effect, safety, and economic evaluation of Maekmoondong-tang administration on patients with nonspecific chronic cough: a randomized, assessor-blind, active-controlled, feasibility clinical trial
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Registration Number
- KCT0007990
- Lead Sponsor
- Daejeon Korean Medicine Hospital of Daejeon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
(1) adults aged 19-75 years at the screening visit
(2) chronic cough patients for more than 8 weeks
(3) those who have voluntarily signed written informed consent approved by the institutional review board, after sufficient explanation of this study
(1) those who have been diagnosed with other causes of chronic coughs, such as chronic respiratory diseases (COPD, bronchial asthma, bronchiectasis, interstitial lung disease, pulmonary tuberculosis, etc.), gastroesophageal reflux disease, chronic sinusitis, and allergic rhinitis within the last 2 years
(2) those who have the following symptoms at the time of screening and the cause of the cough can be assumed: wheezing, chest tightness, dyspnea, runny nose, nasal congestion, sneezing, postnasal drip, abnormal findings in the ear canal, heartburn, reflux, fever, hemoptysis
(3) those with abnormal findings that may cause cough as a result of chest X-ray examination
(4) those with abnormal findings in lung function tests
(5) those with wheezing, rales, postnasal drip, or cobblestone throat on physical examination
(6) those who have been diagnosed with an acute respiratory disease, including an upper respiratory disease, within the last 4 weeks
(7) those who are current smokers, quit smoking within 3 months or have a history of excessive smoking in the past 30 pack years or more
(8) those who are taking ACE inhibitors or DPP-4 inhibitors or have taken them within the last 4 weeks
(9) those who have taken antitussives, expectorants, steroids, anti-leukotrienes, anticholinergics, long-acting beta2 agonists, oral antihistamines, or any herbal medicine within the past 2 weeks
(10) those who have been diagnosed with a malignant tumor within the last 5 years
(11) severe liver or renal disease (aspartate aminotransferase or alanine aminotransferase levels = 3 times upper limit of normal or creatinine levels = 2 times upper limit of normal)
(12) participants with a history of alcohol abuse or drug abuse within the past year
(13) women who are pregnant or lactating, or women who do not agree to use effective methods of contraception during the clinical trial
(14) participants with genetic problems, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
(15) participants with known hypersensitivity to investigational products
(16) participants who had taken other investigational products within 3 months
(17) those who have not recorded a cough diary for at least 7 days immediately prior to the baseline visit
(18) average daytime cough symptom score < 2 points, night-time cough symptom score < 1 point according to the cough diary recorded for the 7 days immediately before the baseline visit
(19) participants who are judged to be inappropriate for participating in this study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method study feasibility (recruitment rate, adherence rate, completion rate, compliance with investigational products, dropout rate, total recruitment period, monthly number of enrolled participants, and cough diary record compliance)
- Secondary Outcome Measures
Name Time Method Cough Symptom Score;Cough VAS (severity, frequency, urge-to-cough) ;Leicester Cough Questionnaire - Korean Verstion;Hull airway reflux questionnaire;Integrative Medicine Outcome Scale;Integrative Medicine Patient Satisfaction Scale;5-level EuroQol 5-dimensional questionnaire/the EuroQol visual analogue scale ;Yin deficiency pattern identificaion score;Blood biomarker (eosinophils, total IgE, plasma fibrinogen);liver and renal function;Incidence of adverse events;Vital signs (blood pressure, pulse, temperature);Cost investigation