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

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

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

Seong-Gyu Ko

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

Keywords

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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