Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT03918538 - A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors N/A
Recruiting NCT05078918 - Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors N/A
Active, not recruiting NCT04548830 - Safety of Lung Cryobiopsy in People With Cancer Phase 2
Completed NCT04633850 - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05583916 - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05898594 - Lung Cancer Screening in High-risk Black Women N/A
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03575793 - A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer Phase 1/Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Terminated NCT03275688 - NanoSpectrometer Biomarker Discovery and Confirmation Study
Not yet recruiting NCT04931420 - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels Phase 2
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Recruiting NCT06052449 - Assessing Social Determinants of Health to Increase Cancer Screening N/A
Not yet recruiting NCT06017271 - Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Recruiting NCT05787522 - Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk