Back to resultsMaekmoondong-tang on Post-operative Cough in Patients With Lung Cancer
Primary Purpose
Postoperative Cough, Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Maekmoondong-tang
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Cough focused on measuring Maekmoondong-tang, Mai-men-dong-tang, Bakumondo-to
Eligibility Criteria
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
Sites / Locations
- Korea University Guro HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MMDT group
Placebo group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Cough VAS
Measure frequency and severity of cough by VAS
Yin deficiency scale
Questionnaire measures yin deficiency
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03384667
Brief Title
Maekmoondong-tang on Post-operative Cough in Patients With Lung Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 22, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
March 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seong-Gyu Ko
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cough, Lung Cancer
Keywords
Maekmoondong-tang, Mai-men-dong-tang, Bakumondo-to
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A randomized, double-blind, placebo-controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MMDT group
Arm Type
Experimental
Arm Title
Placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Maekmoondong-tang
Other Intervention Name(s)
Maekgeuron Granules
Intervention Description
MMDT is a Herbal medicine consist of six herbs.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The granules do not contain any active ingredients.
Primary Outcome Measure Information:
Title
Leicester Cough Questionnaire (LCQ)
Description
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.
Time Frame
Day 0 to Day 28
Secondary Outcome Measure Information:
Title
Cough VAS
Description
Measure frequency and severity of cough by VAS
Time Frame
Day 0 to Day 28
Title
Yin deficiency scale
Description
Questionnaire measures yin deficiency
Time Frame
Day 0 to Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunhoo Cheon, Dr.
Phone
8229619278
Email
hreedom35@gmail.com
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
130-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyojin Son
Phone
82-2-2626-1185
Email
crisphj@naver.com
12. IPD Sharing Statement
Learn more about this trial
Maekmoondong-tang on Post-operative Cough in Patients With Lung Cancer
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