JPRN-jRCTs031210140进行中（未招募）未知
A multi-center, placebo-controlled, double-blind comparative study of Ninjinyoeito for COPD patients with frailty/prefrailty - NYT for COPD
Sagara Hironori0 个研究点目标入组 140 人开始时间: 2021年6月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- •1) COPD patients who are visiting the study facility and have received standard therapy for at least 1 month by the time consent is obtained
- •2) Patient with prefrailty (1 or 2 out of 5 items) or frailty (3 or more items out of 5 items) with any of weight loss, muscle weakness, tiredness, decreased walking speed, and decreased physical activity based on the revised J-CHS criteria
- •3) Patients who have given their informed consent to participate in this study
- •4) Patients with a smoking history of 10 pack years or with same level of air pollution exposure
- •5) Patients with physical weakness, fatigue, loss of appetite, rash, cold limbs, and anemia
排除标准
- •1) Patients who cannot properly perform respiratory function tests
- •2) Patients with clinical respiratory diseases other than COPD (excluding asthma)
- •3) Patients with any acute disease within 3 months of study registration
- •4) Patients with a clear decline in cognitive function
- •5) When walking is extremely difficult due to neurological factors
- •6) Patients who have been taking Kampo medicines within 1 month from the time of obtaining consent
- •7) Patients with active malignant tumor
- •8) Patients who have participated in other clinical trials within the past 1 month
- •9) Patients who was judged to be inadequate according to the judgment of the examination medical attendant
研究者
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