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

Study Overview
=================
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.

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

Conditions
-----------------
Postoperative Cough, Lung Cancer

Intervention / Treatment
-----------------
* Drug: Maekmoondong-tang
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, double-blind, placebo-controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MMDT group<br> | Drug: Maekmoondong-tang<br>* MMDT is a Herbal medicine consist of six herbs.<br>* Other names: Maekgeuron Granules;|
| Placebo Comparator: Placebo group<br> | Drug: Placebo<br>* The granules do not contain any active ingredients.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough VAS | Measure frequency and severity of cough by VAS | Day 0 to Day 28 | 
| Yin deficiency scale | Questionnaire measures yin deficiency | Day 0 to Day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Maekmoondong-tang, Mai-men-dong-tang, Bakumondo-to