NCT03384667Unknown2 期
Efficacy and Safety Evaluation of Maekmoondong-tang on Post-operative Cough in Patients With Lung Cancer -Randomized, Double-blind, Placebo-controlled Clinical Trial
Seong-Gyu Ko1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2018年2月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Leicester Cough Questionnaire (LCQ)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
MMDT group
Experimental
干预措施: Maekmoondong-tang (Drug)
Placebo group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Leicester Cough Questionnaire (LCQ)
时间窗: 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.
次要结局
- Cough VAS(Day 0 to Day 28)
- Yin deficiency scale(Day 0 to Day 28)
研究者
Seong-Gyu Ko
Prof.
Kyunghee University Medical Center
研究点 (1)
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