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Observation on the clinical efficacy of modified Suanzaoren decoction in the treatment of post-stroke insomnia with liver stagnation and blood deficiency type

注册号：

Registration number：

ITMCTR2024000351

最近更新日期：

Date of Last Refreshed on：

2024-09-02

注册时间：

Date of Registration：

2024-09-02

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

酸枣仁汤加减治疗脑卒中后失眠之肝郁血虚型的临床疗效观察

Public title：

Observation on the clinical efficacy of modified Suanzaoren decoction in the treatment of post-stroke insomnia with liver stagnation and blood deficiency type

注册题目简写：

酸枣仁汤加减治疗脑卒中后失眠肝郁血虚型患者的临床疗效

English Acronym：

Clinical efficacy of modified Suanzaoren decoction in the treatment of post-stroke insomnia with liver depression and blood deficiency type patients

研究课题的正式科学名称：

酸枣仁汤加减治疗脑卒中后失眠之肝郁血虚型的临床疗效及作用机制研究

Scientific title：

Clinical efficacy and mechanism of modified Suanzaoren decoction in the treatment of post-stroke insomnia with liver stagnation and blood deficiency type

研究课题的正式科学名称简写：

酸枣仁汤加减治疗脑卒中后失眠之肝郁血虚型的临床疗效观察

Scientific title acronym：

Observation on the clinical efficacy of modified Suanzaoren decoction in the treatment of post-stroke insomnia with liver stagnation and blood deficiency type

研究课题代号(代码)：

Study subject ID：

2024AFD345

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

马哲

研究负责人：

马哲

Applicant：

MA zhe

Study leader：

MA zhe

申请注册联系人电话：

Applicant telephone：

+86 134 7709 8586

研究负责人电话：

Study leader's telephone：

+86 134 7709 8586

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

286778011@qq.com

研究负责人电子邮件：

Study leader's E-mail：

286778011@qq.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website
(voluntary supply)：

申请注册联系人通讯地址：

武汉市江汉区菱角湖路11号湖北省中西医结合医院老年病科一病区

研究负责人通讯地址：

武汉市江汉区菱角湖路11号湖北省中西医结合医院老年病科一病区

Applicant address：

No. 11 Lingjiaohu Road, Jianghan District, Wuhan City, Hubei Province Integrated Traditional Chinese and Western Medicine Hospital Geriatrics Department 1 Ward

Study leader's address：

No. 11 Lingjiaohu Road, Jianghan District, Wuhan City, Hubei Province Integrated Traditional Chinese and Western Medicine Hospital Geriatrics Department 1 Ward

申请注册联系人邮政编码：

Applicant postcode：

430015

研究负责人邮政编码：

Study leader's postcode：

430015

申请人所在单位：

湖北省中西医结合医院

Applicant's institution：

Hubei Integrated Traditional Chinese and Western Medicine Hospital

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

[2024]伦审字(046)号

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

湖北省中西医结合医院医学伦理审查委员会

Name of the ethic committee：

Medical Ethics Review Committee of Hubei Integrated Traditional Chinese and Western Medicine Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024/6/26 0:00:00

伦理委员会联系人：

周爽

Contact Name of the ethic committee：

ZHOU shuang

伦理委员会联系地址：

湖北省武汉市江汉区菱角湖路11号湖北省中西医结合医院科教部

Contact Address of the ethic committee：

No.11 Lingjiaohu Road Jianghan District Wuhan City Hubei Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

15171221120

伦理委员会联系人邮箱：

Contact email of the ethic committee：

hbzxy-lunli2024@126.com

研究实施负责（组长）单位：

湖北省中西医结合医院

Primary sponsor：

Hubei Integrated Traditional Chinese and Western Medicine Hospital

研究实施负责（组长）单位地址：

湖北省武汉市江汉区菱角湖路11号湖北省中西医结合医院老年病科一病区

Primary sponsor's address：

No.11 Lingjiaohu Road Jianghan District Wuhan City Hubei Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖北

市(区县)：

武汉市

Country：

CHINA

Province：

HUBEI

City：

WUHAN

单位(医院)：

湖北省中西医结合医院

具体地址：

武汉市江汉区菱角湖路11号

Institution
hospital：

Hubei Integrated Traditional Chinese and Western Medicine Hospital

Address：

No.11 Lingjiaohu Road, Jianghan District, Wuhan City, Hubei Province

经费或物资来源：

科研经费

Source(s) of funding：

Research funds

研究疾病：

失眠

研究疾病代码：

Target disease：

insomnia

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

其它

Others

研究目的：

目前我国脑卒中患者约占全球的1/5，其中约56%-68％患者发病后出现失眠，且缺血性脑卒中后失眠的比例较出血性更高。失眠引起的日间功能受损，如焦虑、抑郁等，可加重卒中患者不良情绪、认知障碍的程度，并对家庭、社会造成较大负担。因此改善脑卒中后失眠至关重要。西药治疗多以镇静催眠为主，存在一定程度的副作用或依赖性，而中医治疗优势突出。中医认为脑卒中后失眠属于合病，既存在“中风”，也有“不寐”，其病因病机复杂，或因肝郁化火，扰动心神而发；或因肝肾阴虚，心神失养而发。其中，脑卒中后失眠病人以肝郁血虚证多见，《伤寒论》酸枣仁汤可解郁除烦、养血安神，兼之中风后痰、瘀滞络，加活血化瘀、健脾豁痰之品，形成加味酸枣仁汤。临床报道以肝郁血虚证多见。酸枣仁汤清热除烦、养血安神对失眠疗效明显，又因中风后多痰、瘀之邪，或偏于肝郁，或偏于血虚，故临证时多运用酸枣仁汤加减化裁治疗。

Objectives of Study：

At present, about 1/5 of stroke patients in China worldwide, of which about 56% -68% of patients experience insomnia after onset, and the proportion of insomnia after ischemic stroke is higher than that after hemorrhagic stroke. The daytime functional impairment caused by insomnia, such as anxiety and depression, can exacerbate the negative emotions and cognitive impairment of stroke patients, and cause significant burden on their families and society. Therefore, improving insomnia after stroke is crucial. Western medicine treatment mainly relies on sedation and hypnosis, which may have certain side effects or dependencies, while traditional Chinese medicine treatment has outstanding advantages. Traditional Chinese Medicine believes that insomnia after stroke is a comorbidity, which includes both "stroke" and "insomnia". Its etiology and pathogenesis are complex, and it may occur due to liver depression turning into fire, disturbing the mind and spirit; Or it may occur due to liver and kidney yin deficiency and loss of mental and spiritual nourishment. Among them, patients with insomnia after stroke are often diagnosed with liver stagnation and blood deficiency syndrome. According to the Treatise on Cold Damage, Suanzaoren Tang can relieve depression, relieve annoyance, nourish blood and calm the mind. It also has phlegm and stasis stagnation in the meridians after stroke. Adding products that promote blood circulation, remove blood stasis, and invigorate the spleen and phlegm can form a modified Suanzaoren Tang. Clinical reports have shown that liver stagnation and blood deficiency syndrome are more common. Suanzaoren Tang has a significant therapeutic effect on insomnia by clearing heat, eliminating annoyance, nourishing blood, and calming the mind. However, due to the pathogenic factors of excessive phlegm and blood stasis after stroke, which may be biased towards liver depression or blood deficiency, Suanzaoren Tang is often used for reducing symptoms during clinical practice.

药物成份或治疗方案详述：

予以酸枣仁汤加减干预缺血性卒中后失眠（肝郁血虚证）患者，于治疗前后使用匹兹堡睡眠量表（PSQI）、美国国立卫生研究院卒中量表（NIHSS）、中医症候评分进行对比，观察其临床疗效。并分为西药组、联合组进行干预，二组均给予基础内科药物治疗（艾司唑仑、阿司匹林肠溶片、他汀类调脂药物）。联合组再联用酸枣仁汤加减治疗，基础方由酸枣仁 ，知母，茯苓 ，川芎，炙甘草 组成。

Description for medicine or protocol of treatment in detail：

纳入标准：

①经影像学检查确诊为缺血性脑卒中，且符合《中医病证诊断疗效标准》中关于中风、不寐（肝郁血虚证）诊断标准。②已过急性期。③入组时PSQI评分＞7分。④入组前1个月未服用精神类药物。

Inclusion criteria

① Diagnosed as ischemic stroke through imaging examination, and meets the diagnostic criteria for stroke and insomnia (liver depression and blood deficiency syndrome) in the "Diagnostic and Therapeutic Criteria for Traditional Chinese Medicine" The acute phase has passed. ③ At the time of enrollment, the PSQI score was greater than 7 points I did not take any psychotropic drugs in the month before enrollment.

排除标准：

①伴发较为严重的心脑血管疾病或其他未能控制的免疫、血液疾病；②中途退出或依从性差的病例；③治疗过程出现明显不良反应。

Exclusion criteria：

① Accompanied by severe cardiovascular and cerebrovascular diseases or other uncontrollable immune and blood disorders Disease; ② Cases with mid-term withdrawal or poor compliance; ③ Significant adverse reactions occurred during the treatment process.

研究实施时间：

Study execute time：

从From 2024-03-01

至To      2026-03-01

征募观察对象时间：

Recruiting time：

从From 2024-09-16

至To      2026-03-01

干预措施：

Interventions：

组别：

西药组

样本量：

30

Group：

Western Medicine Group

Sample size：

干预措施：

给予基础内科药物治疗（艾司唑仑、阿司匹林肠溶片、他汀类调脂药物）。

干预措施代码：

Intervention：

Provide basic internal medicine medication treatment (such as escitalopram, aspirin enteric coated tablets, statins for lipid regulation).

Intervention code：

组别：

联合组

样本量：

30

Group：

Combined group

Sample size：

干预措施：

除基础内科药物治疗外，再联用酸枣仁汤。

干预措施代码：

Intervention：

In addition to basic internal medicine medication treatment, sour jujube seed soup should be used in combination.

Intervention code：

样本总量 Total sample size ： 60

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

湖北

市(区县)：

武汉市

Country：

CHINA

Province：

HUBEI

City：

WUHAN

单位(医院)：

湖北省中西医结合医院

单位级别：

湖北省中西医结合医院

Institution/hospital：

Hubei Integrated Traditional Chinese and Western Medicine Hospital

Level of the institution：

Hubei Integrated Traditional Chinese and Western Medicine Hospital

测量指标：

Outcomes：

指标中文名：

中医症候评分

指标类型：

次要指标

Outcome：

Traditional Chinese Medicine Syndrome Score

Type：

Secondary indicator

测量时间点：

入组时/治疗结束时

测量方法：

量表

Measure time point of outcome：

Upon enrollment/At the end of treatment

Measure method：

Fill out the scale

指标中文名：

匹兹堡睡眠量表

指标类型：

主要指标

Outcome：

Pittsburgh Sleep Scale

Type：

Primary indicator

测量时间点：

入组时/治疗结束时

测量方法：

填写量表

Measure time point of outcome：

Upon enrollment/At the end of treatment

Measure method：

Fill out the scale

指标中文名：

国立卫生研究院卒中量表

指标类型：

次要指标

Outcome：

NIHSS

Type：

Secondary indicator

测量时间点：

入组时/治疗结束时

测量方法：

填写量表

Measure time point of outcome：

Upon enrollment/At the end of treatment

Measure method：

Fill out the scale

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

其它

说明

Fate of sample 

Others

Note：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 100 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

根据患者招募顺序编号后，再由研究者使用excel表进行随机选取数字编号。

Randomization Procedure (please state who generates the random number sequence and by what method)：

Number the patients and have the researchers randomly select numerical numbers using an Excel spreadsheet.

盲法：

无

Blinding：

None

是否共享原始数据：

IPD sharing：

否

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

不共享

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Not shared

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

采用量表进行评估与收集，采集病例后形成每位患者的对应资料。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Use a scale for evaluation and collection, and form corresponding data for each patient after collecting cases.

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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