Lung Cancer Clinical Trial
Official title:
Efficacy and Safety Evaluation of Maekmoondong-tang on Post-operative Cough in Patients With Lung Cancer -Randomized, Double-blind, Placebo-controlled Clinical Trial
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.
Status | Recruiting |
Enrollment | 96 |
Est. completion date | March 31, 2019 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea University Guro Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seong-Gyu Ko |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Leicester Cough Questionnaire (LCQ) | 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. | Day 0 to Day 28 | |
Secondary | Cough VAS | Measure frequency and severity of cough by VAS | Day 0 to Day 28 | |
Secondary | Yin deficiency scale | Questionnaire measures yin deficiency | Day 0 to Day 28 |
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