Lung Cancer, Postoperative Cough
Conditions
Keywords
Maekmoondong-tang, Mai-men-dong-tang, Bakumondo-to
Brief summary
The aim of the present study is to evaluate the efficacy and safety of Maekmoondong-tang on post-operative cough in patients with lung cancer. A randomized, double-blind, placebo-controlled trial will be conducted.
Interventions
DRUGMaekmoondong-tang
MMDT is a Herbal medicine consist of six herbs.
DRUGPlacebo
The granules do not contain any active ingredients.
Sponsors
Seong-Gyu Ko
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A randomized, double-blind, placebo-controlled trial
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults over 20 years old. * Patients undergone segmentectomy or lobectomy for lung cancer within 1 month * Patients who do not or poorly respond to one week administration of common antitussive agents. * Eastern Cooperative Oncology Group(ECOG) 0 to 2 * Participant is willing and able to give informed consent for participation in the study
Exclusion criteria
* Patients undergoing adjuvant chemotherapy. * Patients who have been diagnosed with acute respiratory disease within 1 month. * Patients who have been diagnosed with bronchial asthma or bronchiectasis within 1 year * Patients taking Angiotensin Converting Enzyme Inhibitor * Patients with pseudoaldosteronism. * Participants who have known prior hypersensitivity to any investigational product component * Patient with acute or chronic infections requiring treatment (active HAV, HBV, HCV, HIV, TB) * Pregnant or lactating females * Women of childbearing potential * Patient who do not agrees to use effective means of contraception and not to donate sperm during the trial and up to 1 month after final administration * Patient who participated other clinical trials of medicine or medical devices within 1 month * Individuals who are judged inappropriate for the study by investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leicester Cough Questionnaire (LCQ) | Day 0 to Day 28 | Questionnaire used to measure quality of life in cough patients. The total score of LCQ is 3 to 21, and a higher score means a better quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cough VAS | Day 0 to Day 28 | Measure frequency and severity of cough by VAS |
| Yin deficiency scale | Day 0 to Day 28 | Questionnaire measures yin deficiency |
Countries
South Korea
Contacts
Primary ContactChunhoo Cheon, Dr.
Outcome results
None listed