研究疾病:
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失眠
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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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析因分组(即根据危险因素或暴露因素分组)
Factorial
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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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1)确定胃失和降法治疗失眠症的疗效; 2)阐明胃失和降法治疗失眠的神经机制。
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Objectives of Study:
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1) To determine the curative effect of gastric loss and health treatment for insomnia; 2) To elucidate the neural mechanism of the treatment of insomnia by gastric loss and health.
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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1. 胃失和降型慢性失眠纳入标准;
2. 符合慢性失眠诊断标准及胃失和降诊断标准,睡眠和觉醒困难不能被其他类型的睡眠障碍更好的解释,同时符合以下7项条件:
①符合失眠障碍诊断标准,符合心脾两虚型原发性失眠标准;
②50周岁≤年龄≤55周岁者;
③未参加其他临床研究者;
④签署知情同意书,自愿参加本项研究者;
⑤匹兹堡睡眠指数(PSQI)指数>7分,阿森斯(AIS)量表积分>6分。抑郁量表(SDS)和焦虑量表(SAS)标准分≤60分者;
⑥观察期内无工作压力和生活压力;
⑦无心脑血管疾病和其他器质性疾病;血尿常规、心电图、脑电图、肝肾功能、血糖血脂等理化检查指标正常。
3. 且上述症状持续1年以上,频率≥3次/周的患者,方可纳入本项研究。
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Inclusion criteria
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1. Inclusion criteria of chronic insomnia with gastric loss and health;
2. Meet the diagnostic criteria for chronic insomnia and stomach loss and health, sleep and wake difficulties cannot be better explained by other types of sleep disorders, and meet the following 7 conditions:
① Meet the diagnostic criteria of insomnia disorder, meet the primary insomnia criteria of heart and spleen deficiency;
② Persons aged 50 ≤55;
③ Did not participate in other clinical investigators;
④ Sign informed consent to participate in this study voluntarily;
(5) Pittsburgh sleep Index (PSQI) score >7, AIS score >6. SDS and SAS scores ≤60;
⑥ During the observation period, there was no work pressure or life pressure;
(7) Cardiovascular diseases and other organic diseases; Routine hematuria, electrocardiogram, electroencephalogram, liver and kidney function, blood glucose and lipid and other physical and chemical examination indicators were normal.
3. Patients with above symptoms lasting for more than 1 year and frequency ≥3 times/week can be included in this study.
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排除标准:
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如果受试者满足下列任何1项条件,其将不能参与此次试验。
1. 由于过度焦虑、抑郁等引起的失眠患者;
2. 患有呼吸相关的睡眠障碍,昼夜节律睡眠障碍和睡眠机能紊乱者;
3. 患全身性疾病,如疼痛、发热、咳嗽等,导致的失眠患者;
4. 合并有心血管、肺、肝、肾和造血系统等严重原发性疾病患者;
5. 精神性疾病患者;
6. 治疗部位皮肤有感染者或皮肤为超敏皮肤;
7. 进展性恶性肿瘤或其它严重消耗性疾病,易合并感染和出血者;
8. 依从性差,未按规定进行治疗的患者;
9. 因某种原因,导致无法判断疗效或资料不全等影响疗效和疗效判断者;
10. 由于滥用药物或药物治疗,引起是失眠患者;
11. 由长期过度饮酒、咖啡、浓茶等,及不良生活因素所致的睡眠障碍者;
12. 妊娠, 月经期或哺乳期妇女。
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Exclusion criteria:
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If a subject meets any of the following conditions, he/she will not be allowed to participate in the study.
1. Insomnia patients caused by excessive anxiety and depression;
2. Respiratory related sleep disorders, circadian rhythm sleep disorders and sleep disorders;
3. Insomnia patients suffering from systemic diseases such as pain, fever, cough, etc.;
4. Patients with cardiovascular, lung, liver, kidney, hematopoietic system and other serious primary diseases;
5. Patients with mental illness;
6. The skin at the treatment site is infected or hypersensitive;
7. Patients with progressive malignant tumors or other serious wasting diseases, which are prone to co-infection and bleeding;
8. Patients who have poor compliance, or fail to receive treatment as required;
9. For some reason, it is impossible to judge the curative effect or incomplete data affects the curative effect and judgement;
10. As a result of drug abuse or drug treatment, caused by insomnia patients;
11. Sleep disorders caused by long-term excessive drinking of alcohol, coffee, strong tea, etc., and adverse life factors;
12. A pregnant, menstruating, or lactating woman.
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研究实施时间:
Study execute time:
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从From
2022-06-01
至To
2023-12-31
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征募观察对象时间:
Recruiting time:
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从From
2022-06-22
至To
2023-08-30
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