- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03384667
Maekmoondong-tang on Post-operative Cough in Patients With Lung Cancer
February 27, 2018 updated by: Seong-Gyu Ko
Efficacy and Safety Evaluation of Maekmoondong-tang on Post-operative Cough in Patients With Lung Cancer -Randomized, Double-blind, Placebo-controlled Clinical Trial
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
96
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 130-701
- Recruiting
- Korea University Guro Hospital
-
Contact:
- Hyojin Son
- Phone Number: 82-2-2626-1185
- Email: crisphj@naver.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo group
|
The granules do not contain any active ingredients.
|
EXPERIMENTAL: MMDT group
|
MMDT is a Herbal medicine consist of six herbs.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Leicester Cough Questionnaire (LCQ)
Time Frame: 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.
|
Day 0 to Day 28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cough VAS
Time Frame: Day 0 to Day 28
|
Measure frequency and severity of cough by VAS
|
Day 0 to Day 28
|
Yin deficiency scale
Time Frame: Day 0 to Day 28
|
Questionnaire measures yin deficiency
|
Day 0 to Day 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 22, 2018
Primary Completion (ANTICIPATED)
December 31, 2018
Study Completion (ANTICIPATED)
March 31, 2019
Study Registration Dates
First Submitted
December 20, 2017
First Submitted That Met QC Criteria
December 20, 2017
First Posted (ACTUAL)
December 27, 2017
Study Record Updates
Last Update Posted (ACTUAL)
February 28, 2018
Last Update Submitted That Met QC Criteria
February 27, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISEE_MMDT_2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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