研究疾病:
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失眠障碍
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研究疾病代码:
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Target disease:
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insomnia
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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其它
Others
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研究目的:
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采用随机、双盲、对照临床研究方法,观察舒和颗粒治疗心肾两虚、气血失和证失眠的临床疗效及安全性,提供高级别循证证据,从而补充心肾两虚、气血失和证失眠中药治疗方案,提高临床疗效,并为舒和颗粒的院内制剂、新药临床开发提供基础
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Objectives of Study:
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A randomized, double-blind, controlled clinical study was conducted to observe the clinical efficacy and safety of Shuhe Granules in the treatment of heart-kidney deficiency and syndrome of qi and blood deficiency, and to provide high-level evidence-based evidence, so as to supplement the traditional Chinese medicine treatment of heart-kidney deficiency and syndrome of qi and blood deficiency, improve clinical efficacy, and provide a basis for the clinical development of Shuhe granules in hospital preparations and new drugs
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药物成份或治疗方案详述:
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参与者将摄入24克SHG颗粒或模拟剂,每天两次。药物及安慰剂由江阴市天江药业(中国江阴市)提供。模拟剂将使用可溶性淀粉、着色剂和苦味添加剂制备,以实现与药物相当的外观、气味和味道。药物和模拟剂在外包装、颜色、形状和风味上是相同的。患者没有服用的药物将退还给研究人员。在研究过程中不应服用其他抗高血压药物。
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Description for medicine or protocol of treatment in detail:
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Participants will ingest 24 g granules of SHG or simulation agent, twice a day. The drugs and placebo will be provided by Jiangyin Tianjiang Pharmaceutical (Jiangyin City, China). The simulation agent will be prepared using soluble starch, colorant, and a bitter additive to achieve appearance, smell, and taste comparable to the drug. The drugs and simulation agents will be identical in outer packaging, color, shape, and flavor. The drug that patients did not take would be returned to the researcher. And no other anti-hypertension drugs should be taken during the study process.
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纳入标准:
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(1)18-70周岁
(2)符合西医慢性失眠诊断标准
符合美国睡眠医学学会制定的新版《International Classification of Sleep DisordersⅢ》的慢性失眠诊断标准
(3)符合舒和颗粒适应症:
同时符合以下三条
a. 匹兹堡睡眠质量指数量表入睡困难因子分≥1
b. 匹兹堡睡眠质量指数量表日间功能因子分≥1
c. 头晕、心悸、月经量少、自汗怕风、四肢发冷、舌白、面色苍白、眼睑苍白或淡红(症状≥3/8)。
同时不能出现以下任意一条
a.下眼睑全红
b.手烘热
c.大便干结、硬
d.苔厚腻或干燥粗糙
e.脉息比大于5.5
(4)签署知情同意书
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Inclusion criteria
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(1) Aged 18-70
(2) In line with Western medicine chronic insomnia diagnostic standards
It is consistent with the diagnostic criteria of chronic insomnia in the new edition of International Classification of Sleep DisordersⅢ formulated by the American Academy of Sleep Medicine
(3) Consistent with the indications of Shuhe granules:
Both of the following three
a. sleep difficulty factor score of Pittsburgh Sleep Quality Index ≥1
b. daytime function factor score of Pittsburgh Sleep Quality Index ≥1
c. Dizziness, palpitation, low menstrual volume, spontaneous sweating, fear of wind, cold limbs, white tongue, pale face, pale or reddish eyelids (symptoms ≥3/8).
None of the following cannot appear at the same time
a. The lower eyelid is completely red
b. Warm hands
c. Dry, stiff stool
d. Thick and greasy or dry and rough moss
e. Pulse ratio greater than 5.5
(4) Sign informed consent
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排除标准:
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(1)准备怀孕或孕期或哺乳期或需要陪伴小孩睡觉的人群。
(2)根据病史与问诊,医生确认由其它疾病引起的继发性失眠。例如:局部的疼痛、不安腿综合征、睡眠呼吸暂停综合征、急慢性心力衰竭、慢性阻塞性肺病、急慢性支气管炎
(3)根据患者抑郁自评工具(PHQ-9)诊断为重度抑郁患者(总分≥15)
(4)根据广泛性焦虑量表(GAD-7)诊断重度焦虑患者(总分≥15)
(4)过去30天内参加过其它药物临床试验者。
(5)合并其他精神疾病者
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Exclusion criteria:
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1.Preparing to become pregnant or during pregnancy or lactation;
2. Secondary insomnia caused by physical disease. For example: local pain, restless leg syndrome, sleep apnea syndrome, acute and chronic heart failure, chronic obstructive pulmonary disease, acute and chronic bronchitis, etc.
3. Secondary insomnia caused by mental disease. For example: Affective disorders, anxiety disorder, depression, schizophrenia, and any other serious mental disorders.
4. A Patient health questionnaire-9 (PHQ-9) score of 15 or higher;
5. A Generalized Anxiety Scale (GAD-7) score of 15 or higher
6. Use of medicine to treatment sleeping disorders in the past two week.
7.Participants in clinical trials of other drugs in the past 30 days;
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研究实施时间:
Study execute time:
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从From
2023-06-06
至To
2024-12-31
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征募观察对象时间:
Recruiting time:
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从From
2023-06-06
至To
2024-12-31
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