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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03384667
• Other study ID #: ISEE_MMDT_2017
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: December 20, 2017
• Last updated: February 27, 2018
• Start date: February 22, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: February 2018
• Source: Kyunghee University Medical Center
• Contact: Chunhoo Cheon, Dr.
• Phone: 8229619278
• Email: hreedom35[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cough
• Lung Cancer
• Lung Neoplasms
• Postoperative Cough

Intervention

Drug:
• Maekmoondong-tang
MMDT is a Herbal medicine consist of six herbs.
• Placebo
The granules do not contain any active ingredients.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seong-Gyu Ko

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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