Maekmoondong-tang on Post-operative Cough in Patients With Lung Cancer

Phase 2

• Conditions: Postoperative Cough; Lung Cancer
• Interventions: Drug: Placebo; Drug: Maekmoondong-tang

• Registration Number: NCT03384667
• Lead Sponsor: Seong-Gyu Ko

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-27
• Status Verified: 2018-02
• Study Start: 2018-02-22
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-02-28
• Primary Completion: 2018-12-31
• Study Completion: 2019-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	-
MMDT group	Maekmoondong-tang	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of