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

NCT ID: NCT03384667

Last Updated: 2018-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-22

Study Completion Date

2019-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Cough Lung Cancer

Keywords

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Maekmoondong-tang Mai-men-dong-tang Bakumondo-to

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, double-blind, placebo-controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MMDT group

Group Type EXPERIMENTAL

Maekmoondong-tang

Intervention Type DRUG

MMDT is a Herbal medicine consist of six herbs.

Placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The granules do not contain any active ingredients.

Interventions

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Maekmoondong-tang

MMDT is a Herbal medicine consist of six herbs.

Intervention Type DRUG

Placebo

The granules do not contain any active ingredients.

Intervention Type DRUG

Other Intervention Names

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Maekgeuron Granules

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seong-Gyu Ko

OTHER

Sponsor Role lead

Responsible Party

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Seong-Gyu Ko

Prof.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Korea University Guro Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Chunhoo Cheon, Dr.

Role: CONTACT

Phone: 8229619278

Email: [email protected]

Facility Contacts

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Hyojin Son

Role: primary

Other Identifiers

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ISEE_MMDT_2017

Identifier Type: -

Identifier Source: org_study_id