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

S

Seong-Gyu Ko

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Postoperative Cough
Lung Cancer

Treatments

Drug: Placebo
Drug: Maekmoondong-tang

Study type

Interventional

Funder types

Other

Identifiers

NCT03384667
ISEE_MMDT_2017

Details and patient eligibility

About

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.

Enrollment

96 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

96 participants in 2 patient groups, including a placebo group

MMDT group
Experimental group
Treatment:
Drug: Maekmoondong-tang
Placebo group
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Chunhoo Cheon, Dr.

Data sourced from clinicaltrials.gov

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