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

NCT03384667 | Unknown Phase 2

• 1 other identifier: ISEE_MMDT_2017
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cough; Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cough VAS

  Day 0 to Day 28

• Yin deficiency scale

  Day 0 to Day 28

Study Arms (2)

MMDT group

EXPERIMENTAL

Drug: Maekmoondong-tang

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Maekmoondong-tang DRUG

MMDT is a Herbal medicine consist of six herbs.

Also known as: Maekgeuron Granules

MMDT group

Placebo DRUG

The granules do not contain any active ingredients.

Placebo group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seong-Gyu Ko: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, 130-701, South Korea

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

maimendongtang

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Chunhoo Cheon, Dr.

CONTACT

8229619278; hreedom35@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Model Details: A randomized, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: December 27, 2017
• Study Start: February 22, 2018
• Primary Completion: December 31, 2018
• Study Completion: March 31, 2019
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

KR (1)