Rhodiola Crenulata as an Adjunctive Therapy in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- six-minute walk distance in meters at week 12.
研究概览
简要总结
We hypothesize that add-on Rhodiola L extract capsule to the regimen of patients with moderate-to-severe COPD (1) may provide a potential of systemic effects of anti-inflammation and anti-oxidation for these patients, and these effects (2) may reflect in the improvement of patients' physiological measurements, quality of life and exercise tolerance.
详细描述
This is a single center, randomized, double-blind, placebo controlled clinical trial.
Eligibility criteria:
- moderate-to-severe COPD patients
- aged 40-80 years,
- abstaining from cigarette smoking or maintaining a stable dose of cigarette consumption,
- no acute exacerbation of COPD,
- clinically being stable for one month and longer,
- not undergoing exercise training program.
Primary endpoint:
six-minute walk distance in meters at week 12.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate-to-severe COPD patients
- •aged 40-80 years,
- •abstaining from cigarette smoking or maintaining a stable dose of cigarette consumption,
- •no acute exacerbation of COPD,
- •clinically being stable for one month and longer,
- •not undergoing exercise training program.
排除标准
- •uncontrolled diabetes mellitus by plasma fasting sugar >200 mg/dl,
- •uremia or CKD stage 5,
- •chronic heart failureby NYFC III,
- •cerebrovascular disease,
- •uncontrolled anemia by Hb < 10 mg/dl,
- •active malignant diseases,
- •other hospitalized acute illness,
- •systemic prednisolone > 10 mg per day.
研究组 & 干预措施
Rhodiola placebo capsules
starch
干预措施: Rhodiola placebo capsules (Drug)
Rhodiola Crenulata
Rhodiola Crenulata
干预措施: Rhodiola Crenulata (Drug)
结局指标
主要结局
six-minute walk distance in meters at week 12.
时间窗: 12 weeks
次要结局
- mid-arm circumference and triceps skin thickness, Borg scale, COPD assessment test score, St. George Respiratory disease questionnaire, hospital anxiety and depression scale(HADS) and maximum cardiopulmonary exercise test(12 weeks)
研究者
GCRC
Chief, Department of Critical Care Medicine and Division of Pulmonary Medicine
Chung Shan Medical University