Status:

UNKNOWN

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

Lead Sponsor:

Seong-Gyu Ko

Conditions:

Postoperative Cough

Lung Cancer

Eligibility:

All Genders

20+ years

Phase:

PHASE2

PHASE3

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

February 22 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 31 2019

Estimated Enrollment :

96 Patients enrolled

Trial Details

Trial ID

NCT03384667

Start Date

February 22 2018

End Date

March 31 2019

Last Update

February 28 2018

Active Locations (1)

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1

Korea University Guro Hospital

Seoul, South Korea, 130-701