研究疾病:
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慢性失眠
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研究疾病代码:
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Target disease:
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Chronic 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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I期临床试验
Phase I clinical trial
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研究目的:
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科学评价脐针干预失眠的有效性和安全性,为失眠障碍提供高质量证据支持的中医特色疗法,为中医药特色技术相关支付政策提供科学证据,为进一步国内外推广应用奠定基础。
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Objectives of Study:
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Objective to evaluate the effectiveness and safety of navel acupuncture intervention on insomnia scientifically, provide high-quality evidence to support TCM characteristic therapy for insomnia, and provide scientific evidence for payment policy of TCM characteristic technology, so as to lay a foundation for further promotion and application at home and abroad.
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药物成份或治疗方案详述:
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将符合纳入标准的患者分为三组。对照组1:思诺思片模拟剂,10mg,qd(睡前服用)+假针刺,每周3次,隔天一次 (思诺思5mg,PRN)。对照组2:思诺思片,10mg,qd(睡前服用)+假针刺,每周3次,隔天一次 (思诺思5mg,PRN)。试验组1:思诺思片模拟剂,10mg,qd(睡前服用)+脐针,每周3次,隔天一次 (思诺思5mg,PRN)。疗程2周。
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Description for medicine or protocol of treatment in detail:
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The patients who met the inclusion criteria were divided into three groups. Control group 1: Sinuosi tablet simulation agent, 10mg, qd (taken before going to bed) + fake acupuncture, 3 times a week, once every other day (Sinosi 5mg, PRN). Control group 2: Sinuosi tablets, 10mg, qd (taken before going to bed) + fake acupuncture, 3 times a week, once every other day (sinuosi 5mg, PRN). Test group 1: Simuosi tablet simulation agent, 10mg, qd (taken before going to bed) + umbilical needle, 3 times a week, once every other day (Sinosi 5mg, PRN). The course of treatment is 2 weeks.
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纳入标准:
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(1)18-60岁;
(2)符合西医慢性失眠诊断标准;
(3)匹兹堡睡眠质量指数表(PSQI)总分>7分;
(4)生命体征平稳,神志清楚,有一定表达能力;
(5)接受干预措施前 2 周内未使用抗抑郁、抗焦虑药物、苯二氮卓类、非苯二氮类药物;
(6)签署知情同意书。
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Inclusion criteria
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(1) 18-60 years old;
(2) Meet the diagnostic criteria of chronic insomnia in western medicine;
(3) Pittsburgh Sleep Quality Index (PSQI) total score>7;
(4) Stable vital signs, clear consciousness, and certain expression skills;
(5) No antidepressant, anti-anxiety drugs, benzodiazepines, or non-benzodiazepine drugs have been used within 2 weeks before receiving intervention measures;
(6) Sign the informed consent form.
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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一起睡觉的人群;
(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)诊断为中、重度抑郁患者(总分≥10);
(4)根据广泛性焦虑量表(GAD-7)诊断中、重度焦虑患者(总分≥10);
(5)合并有心脑血管、肺、肝、肾和内分泌系统等严重疾病者;
(6)精神发育迟滞者、酒精或物质滥用或依赖、自杀倾向者;
(7)过去30天内参加过其它药物临床试验者;
(8)合并其他精神疾病者;
(9)生命体征不稳定者;
(10)严重失语、失认无法沟通者;
(11)脐疝或凝血功能障碍者;
(12)有脐针治疗经历者。
(13)思诺思及酒精过敏者。
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Exclusion criteria:
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(1) People who are planning to become pregnant, pregnant or breastfeeding, or need to accompany their children to sleep together;
(2) According to the medical history and consultation, the doctor confirms the secondary insomnia caused by other diseases;
For example: local pain, restless legs syndrome, sleep apnea syndrome, acute and chronic heart failure, chronic obstructive pulmonary disease, acute and chronic bronchitis;
(3) According to the self-assessment tool for depression (PHQ-9), patients with moderate or severe depression (total score ≥ 10) were diagnosed;
(4) Diagnose moderate and severe anxiety patients (total score ≥ 10) according to the Generalized Anxiety Scale (GAD-7);
(5) Those with serious diseases such as cardiovascular, cerebrovascular, lung, liver, kidney and endocrine system;
(6) People with mental retardation, alcohol or substance abuse or dependence, or suicidal tendency;
(7) Those who have participated in other drug clinical trials in the past 30 days;
(8) People with other mental illnesses;
(9) People with unstable vital signs;
(10) Severe aphasia, ignorance and unable to communicate;
(11) People with umbilical hernia or coagulopathy;
(12) Those who have experience in umbilical acupuncture treatment.
(13) People who are allergic to Sinos and alcohol.
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研究实施时间:
Study execute time:
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从From
2021-01-01
至To
2022-12-31
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征募观察对象时间:
Recruiting time:
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从From
2021-04-15
至To
2022-08-31
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