Traditional Chinese Medicine Suan Tsao Jen Tang and Tian-Wang-Bu-Xin Dan in Patients With Primary Insomnia. A Multi-center Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 128
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
keywords： Traditional Chinese Medicine, Herbs, Clinical trial, Insomnia, Quality of life, Suan-Zao-Ren Tang, Tian-wang-bu-xin-dan
详细描述
Title： Traditional Chinese Medicine Suan Tsao Jen Tang and Tian-Wang-Bu-Xin Dan in patients with primary insomnia. A multi-center, double blind, placebo controlled clinical trial.
(First year of two-years' project)
Design:
Randomized, placebo-controlled trial comprising 3 arms: SZRT, placebo, TWBXD.
Setting:
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Insomnia disorders in patients 20-80 years of age, the Pittsburgh Sleep Assessment Scale (PSQI)> 6 points.
- •No insomnia caused by other diseases. For example: mental illness (depression, etc.), sleep apnea, heart disease (acute myocardial infarction, heart rate is not the whole), hypertension, diabetes, cancer and so on.
- •There are more than a week (including) three times to be more than 30 minutes to fall asleep and sleep less than six hours, there is a continuous months.
- •Test subjects had to really understand the nature of this study, and participants signed consent.
排除标准
- •Before participating in this study, three months, had a major accident or wheel graveyard shift or jet lag problems (such as a long flight).
- •Any insomnia caused by other diseases. For example: mental illness (depression, etc.), sleep apnea, heart disease (acute myocardial infarction), poorly controlled hypertension (> 140 / 90mmHg), poorly controlled diabetes (HbA1C> 7%), cancer, digestive ulcers (undergoing treatment).
- •2 weeks into the experiment of taking melatonin or melatonin agonist, acetylcholine, glutamate, serotonin, norepinephrine, GABA, histamine, adenosine, prostaglandins and other drugs.
- •If patients sleep disorders arise from nighttime urinary frequency. Pregnant or breastfeeding person.
- •Patients unable to read and fill out the questionnaire by themselves this study.
研究组 & 干预措施
TIAN WANG BU XIN DAN
Drug:TIAN WANG BU XIN DAN CONCENRATED GRANULES "CHUANG SONG ZONG"
干预措施: TIAN WANG BU XIN DAN (Drug)
Suan Tzao Ren Tang
Drug:Suan Tzao Ren Tang Granula Subtilae "CHUANG SONG ZONG"
干预措施: Suan Tzao Ren Tang (Drug)
Placebo
Drug:1/10 TIAN WANG BU XIN DAN
干预措施: Placebo (Drug)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: 4 weeks
次要结局
- World Health Organization Quality of Life questionnaire(4 weeks)
研究者
GCRC
Chief, Department of Critical Care Medicine and Division of Pulmonary Medicine
Chung Shan Medical University