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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03384667
Other study ID # ISEE_MMDT_2017
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received December 20, 2017
Last updated February 27, 2018
Start date February 22, 2018
Est. completion date March 31, 2019

Study information

Verified date February 2018
Source Kyunghee University Medical Center
Contact Chunhoo Cheon, Dr.
Phone 8229619278
Email hreedom35@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 96
Est. completion date March 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Maekmoondong-tang
MMDT is a Herbal medicine consist of six herbs.
Placebo
The granules do not contain any active ingredients.

Locations

Country Name City State
Korea, Republic of Korea University Guro Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seong-Gyu Ko

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Cough VAS Measure frequency and severity of cough by VAS Day 0 to Day 28
Secondary Yin deficiency scale Questionnaire measures yin deficiency Day 0 to Day 28
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