KCT0002869招募中未知
Efficacy of Yokukansankachimpihange on insomnia in patients with Parkinson’s disease: A pilot study of Randomized, Doble blind, Placebo-Controlled, Parallel trial
Dunsan Korean Medicine Hospital of Daejeon University0 个研究点目标入组 34 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- o Limit 至 o Limit（—）
- 性别
- All
入选标准
- •(1) K-FRAIL scale ? 1
- •(2) STAI ? 41 (for man), STAI ? 42 (for woman)
- •(3) SCOPA -night score ? 7
- •(4) A diagnosis of PD made by a neurologist
- •(5) Patients who corresponds to Hoehn and Yahr scale stage 1–4
- •(6) Patients who voluntarily participated in the trial and Informed consent completed
排除标准
- •(1) Patients with Alzheimer’s dementia, vascular dementia, Huntington's disease, Amyotrophic lateral sclerosis or hydrocephalus
- •(2) Gait disturbance caused by stroke, brain tumor, or other brain disease
- •(3) A diagnosis of gastrointestinal disease, endocrine disease, or cardiovascular disease not controlled by diet or medication
- •- Persons with a history of gastrointestinal disorders (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of the test drug.
- •- Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •(4) AST or ALT exceeds twice the upper limit of the reference range or the total bilirubin exceeds twice the upper limit of the reference range
- •(5) Kidney disease such as kidney dialysis (liver cancer, cirrhosis, chronic kidney failure, congestive heart failure, etc.)
- •(6) Unstable medical condition as decided by the research clinician
- •(7) If the attending physician determines that there is a significant physical or mental deficiency that does not understand and can not follow the overall treatment
- •(8) Take a herb medication for PD within the last 4 weeks
- •(9) Clinical laboratory abnormality such as serum creatinine =97mmol/L, alanine amino transferase =40U/L, aspartate amino transferase =40U/L)
- •(10) Inability to undergo fNIRS
- •(11) According to the researcher's judgment, patients who are not eligible to participate in this clinical study
研究者
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