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Clinical study on the combined treatment of acupuncture and medication for vascular cognitive impairment based on Yangming's theory of blood storage

注册号：

Registration number：

ITMCTR2025000466

最近更新日期：

Date of Last Refreshed on：

2025-03-05

注册时间：

Date of Registration：

2025-03-05

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

基于阳明蓄血理论针药结合治疗血管性认知障碍的临床研究

Public title：

Clinical study on the combined treatment of acupuncture and medication for vascular cognitive impairment based on Yangming's theory of blood storage

注册题目简写：

针药结合用于血管性认知障碍的临床研究

English Acronym：

Clinical study on the combination of acupuncture and medication for vascular cognitive impairment

研究课题的正式科学名称：

基于阳明蓄血理论针药结合治疗血管性认知障碍的临床研究

Scientific title：

Clinical study on the combined treatment of acupuncture and medication for vascular cognitive impairment based on Yangming's theory of blood storage

研究课题的正式科学名称简写：

针药结合用于血管性认知障碍的临床研究

Scientific title acronym：

Clinical study on the combination of acupuncture and medication for vascular cognitive impairment

研究课题代号(代码)：

Study subject ID：

2024ZYYB017

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：

吴红全

研究负责人：

武增艳

Applicant：

Wu hongquan

Study leader：

Wu zengyan

申请注册联系人电话：

Applicant telephone：

+86 13753817829

研究负责人电话：

Study leader's telephone：

+86 182 3516 7292

申请注册联系人传真 ：

Applicant Fax：

none

研究负责人传真：

Study leader's fax：

none

申请注册联系人电子邮件：

Applicant E-mail：

2350925426@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1105567640@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：

山西省太原市杏花岭区东华门20号院

研究负责人通讯地址：

山西省太原市小店区平阳路北园街 2 号

Applicant address：

No. 20 Donghuamen Courtyard Xinghualing District Taiyuan City Shanxi Province

Study leader's address：

No. 2 Beiyuan Street Pingyang Road Xiaodian District Taiyuan City Shanxi Province

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

山西中医药大学针灸推拿学院

Applicant's institution：

Acupuncture and moxibustion and Massage College of Shanxi University of Traditional Chinese Medicine

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：

伦审科2025第02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：

山西省针灸医院伦理委员会

Name of the ethic committee：

Ethics Committee of acupuncture and moxibustion Hospital of Shanxi Province

伦理委员会批准日期：

Date of approved by ethic committee：

2025/2/17 0:00:00

伦理委员会联系人：

张天生

Contact Name of the ethic committee：

Zhang tiansheng

伦理委员会联系地址：

山西省太原市小店区平阳路北园街 2 号

Contact Address of the ethic committee：

No. 2 Beiyuan Street Pingyang Road Xiaodian District Taiyuan City Shanxi Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

13466838493

伦理委员会联系人邮箱：

Contact email of the ethic committee：

zts910@163.com

研究实施负责（组长）单位：

山西省针灸医院

Primary sponsor：

Shanxi Provincial Acupuncture and Moxibustion Hospital

研究实施负责（组长）单位地址：

山西省太原市小店区平阳路北园街 2 号

Primary sponsor's address：

No. 2 Beiyuan Street Pingyang Road Xiaodian District Taiyuan City Shanxi 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)：

山西省

市(区县)：

太原市

Country：

CHINA

Province：

Shanxi Province

City：

Tai yuan

单位(医院)：

山西省针灸医院

具体地址：

山西省太原市小店区平阳路北园街 2 号

Institution
hospital：

Shanxi Provincial Acupuncture and Moxibustion Hospital

Address：

No. 2 Beiyuan Street Pingyang Road Xiaodian District Taiyuan City Shanxi Province

经费或物资来源：

山西省中医药管理局资助

Source(s) of funding：

Supported by Shanxi Provincial Administration of Traditional Chinese Medicine

研究疾病：

血管性认知障碍

研究疾病代码：

Target disease：

vascular cognitive impairment

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：

探索性研究/预试验

Pilot clinical trial

研究目的：

证明从阳明蓄血角度，采用针刺与抵当汤结合的方法治疗VCI患者有着良好疗效

Objectives of Study：

Prove that from the perspective of Yangming blood storage the combination of acupuncture and Didang decoction has a good therapeutic effect on VCI patients

药物成份或治疗方案详述：

治疗方法 基础治疗：参照《中国脑血管病临床管理指南（第2版）》，给予患者稳定血压、控制血糖调节血脂等对症治疗基础疾病。4周为1疗程，共治疗2疗程。 对照组治疗：在基础治疗上给予盐酸多奈哌齐片。 盐酸多奈哌齐用法： 一日1次，1次5mg，睡前服用。连用4周后临床评估，可增加至一日1次，1次10mg，4周为1疗程，共治疗2疗程。 观察组治疗：在对照组基础上使用针刺联合抵当汤丸剂。 针刺治疗： ①取穴：百会、四神聪、神庭、本神（双侧）、太溪、悬钟、内关、膈俞、血海、三阴交。（穴位来自智三针及中国中医药出版社第十版《针灸学》） ②操作：头部穴位：选用华佗牌0.25mm*30mm一次性使用无菌针灸针，指导患者处舒适体位，充分暴露施针部位，消毒后平刺进针，得气后以180-200r/min捻转持续2 min。针刺体针：选用华佗牌0.35*40mm一次性使用无菌针灸针，指导患者处舒适体位，充分暴露施针部位，消毒后直刺进针，得气后捻转30s，留针30min。 ③疗程：每日1次，每周6次，休息1d，4周为1疗程，共2个疗程。 抵当丸方剂组成：每丸含生药水蛭0.5g、桃仁1g、酒大黄1g、虻虫0.5g，每丸重约3g（由山西省针灸医院制作成丸剂），每次5丸，分早晚2次口服

Description for medicine or protocol of treatment in detail：

therapeutic method Basic treatment: According to the Chinese Clinical Management Guidelines for Cerebrovascular Disease (2nd edition) patients are given symptomatic treatment for basic diseases such as stabilizing blood pressure controlling blood sugar and regulating blood lipids. Four weeks is one course of treatment for a total of two courses of treatment. Control group treatment: Administer donepezil hydrochloride tablets in addition to basic treatment. Dosage of donepezil hydrochloride: Take 5mg once a day before bedtime. After 4 weeks of continuous use the clinical evaluation can be increased to once a day 10mg per time with 4 weeks as one course of treatment for a total of 2 courses of treatment. Observation group treatment: Acupuncture combined with Didang Tang pills was used on the basis of the control group. Acupuncture treatment: ① Acupoint selection: Baihui Sishen Cong Shenting Benshen (bilateral) Taixi Xuanzhong Neiguan Geshu Xuehai Sanyinjiao. (Acupoints are from Zhisanzhen and acupuncture and moxibustion and Moxibustion the tenth edition of China Traditional Chinese Medicine Press) ② Operation: Head acupoints: Huatuo brand 0.25 mm * 30 mm disposable sterile acupuncture and moxibustion needles were selected to guide patients to a comfortable position fully expose the needle application site and after disinfection the needles were inserted horizontally. After obtaining qi the needles were twisted at 180-200r/min for 2 minutes. Acupuncture body acupuncture: 0.35 * 40mm disposable sterile acupuncture and moxibustion needles of Huatuo brand were selected to guide patients to a comfortable position fully expose the needle application site directly puncture the needle after disinfection twist for 30s after getting qi and retain the needle for 30min. ③ Course of treatment: once a day 6 times a week 1 day off 4 weeks as one course of treatment a total of 2 courses. Composition of Didang Pill: each pill contains 0.5g of raw leech 1g of peach kernel 1g of wine rhubarb 0.5g of tabanus and each pill weighs about 3g (made into pills by acupuncture and moxibustion Hospital of Shanxi Province) 5 pills each time twice in the morning and evening

纳入标准：

（1）符合VCI西医诊断标准。 （2）符合中医瘀血阻络证候诊断标准。 （3）年龄40—80岁。 （4）自愿参加并签署知情同意书者。 注：同时满足以上纳入标准。

Inclusion criteria

(1) Meets the diagnostic criteria of VCI Western medicine. (2) Meets the diagnostic criteria of traditional Chinese medicine for blood stasis and obstruction of collaterals syndrome. (3) Age range: 40-80 years old. (4) Those who voluntarily participate and sign the informed consent form. Note: Simultaneously meet the above inclusion criteria.

排除标准：

（1）哺乳妊娠或正准备妊娠的妇女。 （2）过敏体质及对多种药物过敏者。 （3）抑郁量表评分（CSDD）（见附录二）≥8分为抑郁症。 （4）伴有严重的神经缺损患者，如各种失语、失认等。 （5）合并消化、心血管、肝、肾和造血系统等严重原发性疾病、精神病患者。 （6）中毒、头部外伤、遗传病等原因引起的认知功能障碍。 （7）在治疗前一个月内服用中、西促智药物者。 注：符合1项即排除。

Exclusion criteria：

(1) Women who are breastfeeding or preparing for pregnancy. (2) Allergic constitution and individuals who are allergic to multiple medications. (3) A score of ≥ 8 on the Depression Rating Scale (CSDD) (see Appendix 2) is considered depression. (4) Patients with severe neurological deficits such as various types of aphasia dementia etc. (5) Patients with severe primary diseases such as digestive cardiovascular liver kidney and hematopoietic systems as well as psychiatric disorders. (6) Cognitive impairment caused by poisoning head trauma genetic diseases and other reasons. (7) Those who have taken traditional Chinese and Western medicine to promote intelligence within one month before treatment. Note: If one item is met it will be excluded.

研究实施时间：

Study execute time：

从From 2023-08-01

至To      2025-09-01

征募观察对象时间：

Recruiting time：

从From 2025-02-17

至To      2025-08-01

干预措施：

Interventions：

组别：

治疗组

样本量：

39

Group：

Treatment group

Sample size：

干预措施：

对照组基础上使用针刺联合抵当丸

干预措施代码：

Intervention：

On the basis of the control group, acupuncture combined with Didang Pill was used

Intervention code：

组别：

对照组

样本量：

39

Group：

control group

Sample size：

干预措施：

基础治疗上使用盐酸多奈哌齐片

干预措施代码：

Intervention：

Use donepezil hydrochloride tablets on basic treatment

Intervention code：

样本总量 Total sample size ： 78

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

山西省

市(区县)：

Country：

CHINA

Province：

Shanxi Province

City：

单位(医院)：

山西省针灸医院

单位级别：

三甲

Institution/hospital：

Shanxi Provincial Acupuncture and Moxibustion Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

简易智力状态检查量表

指标类型：

主要指标

Outcome：

Minimum Mental State Examination(MMSE)

Type：

Primary indicator

测量时间点：

试验治疗前和治疗结束后

测量方法：

评分表

Measure time point of outcome：

Before and after experimental treatment

Measure method：

Scoring table

指标中文名：

中医证候评分

指标类型：

次要指标

Outcome：

Traditional Chinese Medicine Syndrome Score

Type：

Secondary indicator

测量时间点：

试验治疗前和治疗结束后

测量方法：

评分表

Measure time point of outcome：

Before and after experimental treatment

Measure method：

Scoring table

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

none

Tissue：

none

人体标本去向

使用后销毁

说明

none

Fate of sample 

Destruction after use

Note：

none

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 40 岁
Min age years
最大 80 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）：

如果招募到受试者，根据就诊顺序，将符合纳入标准的病例按随机数字表，将写有随机分组数字的卡片置于信封密封。符合纳入标准的受试者随机抽取信封，按信封内的随机数字随机分成2组，观察组和对照组

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

If participants are recruited according to the order of treatment the cases that meet the inclusion criteria will be randomly assigned to a random number table and cards with random grouping numbers will be placed in sealed envelopes. Participants who meet the inclusion criteria will be randomly selected from envelopes and divided into two groups based on the random numbers inside the envelopes: the observation group and the control group

盲法：

两组均设单盲（数据分析者不知道患者研究治疗方案）

Blinding：

Both groups were single blinded (data analysts were unaware of the patient's study treatment plan)

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）：

项目组根据研究进程择期选择具体方式公开原始数据

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

The project team selects a specific method to publicly disclose the raw data based on the research progress and schedule

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：

研究者根据受试者的原始观察记录，将数据及时、完整、准确的录入病例报告表，录入采用相应的数据库系统双人双机录入，之后对数据库进行两遍对比，电子数据文件分类保存，并有多个备份保存于不同磁盘或者记录介质上，妥善保存，防止损坏

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

Based on the original observation records of the subjects the researchers timely completely and accurately entered the data into the case report form. The data was entered using a corresponding database system with two people and two machines and then the database was compared twice. The electronic data files were classified and saved and multiple backups were saved on different disks or recording media to prevent damage

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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