Evaluation of the Three-Seeds Mixture Treatment in Chronic Obstructive Pulmonary Disease Patients: A Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- Sputum and cough score
研究概览
简要总结
The purpose of this study is to test whether the three-seeds mixture tea reduces sputum and/or cough in COPD patients, and if so, to evaluate whether the three-seeds mixture changes the lung microbiome.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females ages 50-80 at the time of entry
- •Non-smoker for at least 1 year
- •Chronic bronchitis with Fev1 <80% and Fev1/ Fvc <0.7 and daily sputum production
- •Documentation of COPD. We define COPD as the presence of irreversible airflow obstruction, presence of emphysema on CT scan or both. This determination will be by the pulmonary physicians leading this study.
- •Ability and willingness to provide informed consent.
排除标准
- •Current Smoker
- •Asthma or other respiratory diseases
- •Frail patients (unintended weight loss, long term fatigue).
- •Patients with acute COPD exacerbation
研究组 & 干预措施
Tea2 group
This is the control group. This group will be taking 0.02 grams of the "three-seeds" mixture once a day for three weeks.
干预措施: Control (Dietary Supplement)
Tea1 group
This is the treatment group. This group will be taking 2 grams of the "three-seeds" mixture twice a day for three weeks.
干预措施: Three-seeds mixture (Dietary Supplement)
结局指标
主要结局
Sputum and cough score
时间窗: One month
Sputum and cough measured by Cough and Sputum Assessment Questionnaire. The minimum score of this questionnaire is 0, and the maximum score is 100, with lower scores indicating higher symptom/impact levels. The total score will be reported. The score will be summed to a total score.
次要结局
未报告次要终点
研究者
Fei Tang
Research Health Scientist
Veterans Affairs Medical Center, Miami