Postoperative CoughPhase 2/3NCT03384667
Maekmoondong-tang on Post-operative Cough in Patients With Lung Cancer
A Phase 2/3 study testing Maekmoondong-tang in people with Postoperative Cough and Lung Cancer, run by Seong-Gyu Ko at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Postoperative Cough, Lung Cancer
- What is being tested?
- Maekmoondong-tang
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Feb 2018to 31 Mar 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Guro Hospital
Seoul, 130-701
Hyojin Son, 82-2-2626-1185, crisphj@naver.com
About this study
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
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
- Being tested
- Maekmoondong-tang, Placebo
- Keywords
- Maekmoondong-tang, Mai-men-dong-tang, Bakumondo-to
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maekmoondong-tangDrug
Also called Maekgeuron Granules
MMDT is a Herbal medicine consist of six herbs.
PlaceboDrug
The granules do not contain any active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| MMDT group | Experimental | Not described Receives: Drug: Maekmoondong-tang |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 to Day 28
Secondary outcomes (2)
Cough VAS
Measure frequency and severity of cough by VAS
Measured: Day 0 to Day 28
Yin deficiency scale
Questionnaire measures yin deficiency
Measured: Day 0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start22 Feb 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-blind, placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seong-Gyu Ko
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seong-Gyu Ko, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384667
- Sponsor's protocol ID
- ISEE_MMDT_2017
- Status last verified
- Feb 2018
- First submitted
- 20 Dec 2017
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03384667
- Acronym / sponsor ID
- ISEE_MMDT_2017
- Conditions
- Postoperative Cough, Lung Cancer
- Keywords
- Maekmoondong-tang, Mai-men-dong-tang, Bakumondo-to
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Seong-Gyu KoUniversity, hospital or other
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| MMDT group | Experimental | Drug: Maekmoondong-tang |
| Placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maekmoondong-tangAlso: Maekgeuron GranulesMMDT is a Herbal medicine consist of six herbs. | Drug | MMDT group |
| PlaceboThe granules do not contain any active ingredients. | Drug | Placebo group |
Primary outcome
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.
2 secondary outcomes
Cough VAS
Time frame: Day 0 to Day 28
Yin deficiency scale
Time frame: Day 0 to Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Maekmoondong-tang in people with Postoperative Cough and Lung Cancer, run by Seong-Gyu Ko at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunhoo Cheon, Dr. (8229619278, hreedom35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leicester Cough Questionnaire (LCQ) (time frame: Day 0 to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.