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Real-World Study of Zishen Yizhi Pill in Treating Cognitive Impairment Associated with Cerebral Small Vessel Disease (Yin Deficiency and Blood Stasis Syndrome)

注册号：

Registration number：

ITMCTR2025000553

最近更新日期：

Date of Last Refreshed on：

2025-03-20

注册时间：

Date of Registration：

2025-03-20

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

滋肾益智丸治疗脑小血管病认知障碍（阴虚血瘀证）的真实世界研究

Public title：

Real-World Study of Zishen Yizhi Pill in Treating Cognitive Impairment Associated with Cerebral Small Vessel Disease (Yin Deficiency and Blood Stasis Syndrome)

注册题目简写：

English Acronym：

研究课题的正式科学名称：

滋肾益智丸治疗脑小血管病认知障碍（阴虚血瘀证）的真实世界研究

Scientific title：

Real-World Study of Zishen Yizhi Pill in Treating Cognitive Impairment Associated with Cerebral Small Vessel Disease (Yin Deficiency and Blood Stasis Syndrome)

研究课题的正式科学名称简写：

Scientific title acronym：

研究课题代号(代码)：

Study subject ID：

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：

谢乐

研究负责人：

伍大华

Applicant：

Xie le

Study leader：

Wu dahua

申请注册联系人电话：

Applicant telephone：

13548659005

研究负责人电话：

Study leader's telephone：

13508491768

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：

1289398706@qq.com

研究负责人电子邮件：

Study leader's E-mail：

893049352@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：

湖南省长沙市麓山路58号

研究负责人通讯地址：

湖南省长沙市麓山路58号

Applicant address：

No. 58 Lushan Road Changsha Hunan Province China

Study leader's address：

No. 58 Lushan Road Changsha Hunan Province China

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：

湖南省中西医结合医院（湖南省中医药研究院附属医院）

Applicant's institution：

Hunan Provincia Hospital of Integrated Traditional Chinese and Western Medicine ( The Affiliated Hospital of Hunan Academy 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【2025】102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：

湖南省中医药研究院附属医院伦理委员会

Name of the ethic committee：

The Ethics Committee of the Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025/3/5 0:00:00

伦理委员会联系人：

戎宽

Contact Name of the ethic committee：

Rong kuan

伦理委员会联系地址：

湖南省长沙市麓山路58号

Contact Address of the ethic committee：

No. 58 Lushan Road Changsha Hunan Province China

伦理委员会联系人电话：

Contact phone of the ethic committee：

15273110954

伦理委员会联系人邮箱：

Contact email of the ethic committee：

87048174@qq.com

研究实施负责（组长）单位：

湖南省中西医结合医院（湖南省中医药研究院附属医院）

Primary sponsor：

Hunan Provincia Hospital of Integrated Traditional Chinese and Western Medicine ( The Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine)

研究实施负责（组长）单位地址：

湖南省长沙市麓山路58号

Primary sponsor's address：

No. 58 Lushan Road Changsha Hunan Province China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖南

市(区县)：

长沙

Country：

China

Province：

Hunan

City：

Changsha

单位(医院)：

湖南省中西医结合医院（湖南省中医药研究院附属医院）

具体地址：

湖南省长沙市麓山路58号

Institution
hospital：

Hunan Provincia Hospital of Integrated Traditional Chinese and Western Medicine ( The Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine)

Address：

No. 58 Lushan Road Changsha Hunan Province China

经费或物资来源：

芙蓉实验室

Source(s) of funding：

Furong Laboratory

研究疾病：

脑小血管病认知障碍

研究疾病代码：

Target disease：

cognitive impairment of cerebral small vessel disease

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

非随机对照试验

Non randomized control

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

分析评价真实世界中滋肾益智丸治疗脑小血管病认知障碍（阴虚血瘀证）的疗效特点和安全性。

Objectives of Study：

To analyze and evaluate the efficacy characteristics and safety of Zishen Yizhi Wan in the treatment of cognitive impairment due to cerebral small vessel disease (Yin Deficiency and Blood Stasis Syndrome) in real-world settings.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

(1) 年龄≥60岁； (2) 存在脑小血管病认知障碍； (3) 符合阴虚血瘀证中医辨证标准； (4) 患者或其法定代理人自愿参加试验并签署知情同意书。

Inclusion criteria

(1) Age ≥ 60 years; (2) Presence of cognitive impairment due to cerebral small vessel disease; (3) Meeting the diagnostic criteria for Yin Deficiency and Blood Stasis Syndrome according to Traditional Chinese Medicine (TCM) standards; (4) Voluntary participation in the trial and signing of the informed consent form by the patient or their legal representative.

排除标准：

(1) 合并阿尔茨海默病、额颞叶痴呆、路易体痴呆、帕金森病、多发性硬化、脑外伤、自身免疫性疾病、遗传性疾病所介导的等其他导致认知障碍神经系统疾病； (2) 合并有意识障碍，或血压、呼吸、心率等生命体征不平稳，或严重心肺疾病等情况，研究者认为不适合参加本研究； (3) 因精神疾患或情绪障碍、严重视听障碍等无法理解和/或服从研究程序和/或随访; (4) 合并有严重肝、肾、消化系统或造血系统等疾病者。

Exclusion criteria：

(1) Presence of other neurological diseases leading to cognitive impairment such as Alzheimer's disease frontotemporal dementia Lewy body dementia Parkinson's disease multiple sclerosis traumatic brain injury autoimmune diseases or genetic disorders; (2) Presence of impaired consciousness unstable vital signs (e.g. blood pressure respiration heart rate) or severe cardiopulmonary diseases as determined by the investigator to be unsuitable for participation in this study; (3) Inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders emotional disturbances or severe visual/auditory impairments; (4) Presence of severe liver kidney digestive system or hematopoietic system diseases.

研究实施时间：

Study execute time：

从From 2025-04-01

至To      2027-04-01

征募观察对象时间：

Recruiting time：

从From 2025-04-15

至To      2026-12-31

干预措施：

Interventions：

组别：

对照组

样本量：

78

Group：

Control group

Sample size：

干预措施：

基于指南的规范化内科治疗

干预措施代码：

Intervention：

Guideline-based standardized internal medicine treatment

Intervention code：

组别：

治疗组

样本量：

78

Group：

Treatment Group

Sample size：

干预措施：

滋肾益智丸

干预措施代码：

Intervention：

Zishen Yizhi Wan

Intervention code：

样本总量 Total sample size ： 156

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

湖南

市(区县)：

长沙

Country：

China

Province：

Hunan

City：

Changsha

单位(医院)：

湖南省中西医结合医院（湖南省中医药研究院附属医院）

单位级别：

三甲医院

Institution/hospital：

Hunan Provincia Hospital of Integrated Traditional Chinese and Western Medicine ( The Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine)

Level of the institution：

Third-class hospital

测量指标：

Outcomes：

指标中文名：

简易精神状态检查量表

指标类型：

次要指标

Outcome：

Minimum Mental State Examination

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

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：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

蒙特利尔认知评估量表

指标类型：

主要指标

Outcome：

Montreal Cognitive Assessment

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

霍普金斯语言学习测试

指标类型：

次要指标

Outcome：

Hopkins Verbal Learning Test

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

医院焦虑抑郁量表

指标类型：

次要指标

Outcome：

Hospital anxiety and depression scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血管性痴呆评估量表

指标类型：

次要指标

Outcome：

Vascular dementia assessment scale-cog

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

连线试验

指标类型：

次要指标

Outcome：

trail making test

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

画钟试验

指标类型：

次要指标

Outcome：

Clock Drawing Test

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

神经精神问卷

指标类型：

次要指标

Outcome：

neuropsychiatric inventory

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

波士顿命名测试第2版

指标类型：

次要指标

Outcome：

Boston naming test-2

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

欧洲五维健康量表

指标类型：

次要指标

Outcome：

EuroQol Five Dimensions Questionnaire

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

工具性日常生活能力量表

指标类型：

次要指标

Outcome：

Instrumental Activity of Daily Living

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

尿液

组织：

Sample Name：

Urine

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

标本中文名：

粪便

组织：

Sample Name：

Stool

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 60 岁
Min age years
最大 90 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）：

符合入组条件的受试者是根据是否服用中药各自匹配到相应组别，即治疗组（滋肾益智丸 + 基于指南的规范化内科治疗）和对照组（基于指南的规范化内科治疗）

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

Eligible participants will be assigned to respective groups based on whether they are taking traditional Chinese medicine (TCM) specifically the treatment group (Zishen Yizhi Wan + guideline-based standardized internal medicine treatment) or the control group (guideline-based standardized internal medicine treatment alone).

盲法：

Blinding：

是否共享原始数据：

IPD sharing：

是

Yes

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）：

研究结束后 6 个月/在相关研究论文正式发表后的 30 天内

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

6 months after the completion of the study / Within 30 days after the formal publication of the relevant research paper

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：

病例记录表 (CRF) 设计依据：依据研究目的、观察指标及诊疗指南设计，涵盖受试者基本信息、病史、诊断、治疗及观察指标数据，全面收集脑小血管病认知障碍（阴虚血瘀证）及滋肾益智丸治疗效果信息。 记录内容： 基本信息：年龄、性别、联系方式、主诉、病史等。 诊断相关：脑小血管病认知障碍诊断（头颅 MRI、MoCA、TMT-A/B 评分）及中医辨证（阴虚证、血瘀证症状得分）。 治疗信息：治疗组（滋肾益智丸剂量、时间）与对照组（指南规范化内科治疗）方案。 观察指标：第 4、8、12 周访视时记录疗效（MoCA、MMSE 评分）及安全性指标（生命体征、血常规、尿常规、肝肾功能等）。 填写规范：标准化 CRF，首次记录准确，培训记录人员，错误处划双线更正并签名注明日期。 电子采集和管理系统 (EDC) 系统选择：基于 EDC 平台，支持纸质 CRF 数据电子化采集与管理，提高效率与准确性。 数据采集功能： 数据录入：双人独立录入，系统实时校验数据格式与逻辑关系。 数据核对：系统自动交叉核对，标记不一致处并生成质疑，发送研究人员核实处理。 数据管理功能： 质疑处理：系统发送质疑，研究人员解释或更正，处理过程记录于系统。 数据审核：定期审核数据完整性及准确性，解决缺失、异常值等问题。 数据锁定：问题解决后锁定数据库，防止未经授权更改。 数据备份：定期备份，存储于多种介质并异地保存。 数据保密：通过权限管理、数据加密确保保密性。 数据报告：研究结束后生成报告，总结数据收集、处理及清理过程。

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

Case Record Form (CRF) Design Basis: The CRF of this study is designed based on the research objectives observation indicators and relevant diagnosis and treatment guidelines. To comprehensively collect information related to cognitive impairment in cerebral small vessel disease (syndrome of yin deficiency and blood stasis) and the therapeutic effect of Zishen Yizhi Pills it covers the basic information of subjects medical history diagnostic data treatment process and data of observation indicators. Record Content Basic Information: It includes demographic information of the subjects such as age gender contact information as well as clinical data like chief complaints current medical history past medical history and allergy history. Diagnosis - related: Records the diagnostic basis of cognitive impairment in cerebral small vessel disease such as imaging examination results (relevant indicators of cranial MRI) results of neuropsychological measurements (scores of the Montreal Cognitive Assessment Scale MoCA Trail - Making Test TMT - A and TMT - B etc.) and the traditional Chinese medicine (TCM) syndrome differentiation information of the syndrome of yin deficiency and blood stasis (scores of various symptoms of yin deficiency syndrome and blood stasis syndrome). Treatment Information: Details the treatment regimens of the treatment group and the control group. For example the dosage and administration time of Zishen Yizhi Pills in the treatment group and the specific measures of standardized internal medicine treatment based on guidelines for both groups. Observation Indicator Data: At different visit time points during the treatment process (the 4th week ± 3 days the 8th week ± 3 days and the 12th week ± 3 days) data of efficacy indicators (such as MoCA scores Mini - Mental State Examination MMSE scores etc.) and safety indicators (results of vital signs blood routine urine routine liver and kidney function tests etc.) are recorded. Filling Specifications: Standardized CRFs are used for data collection to ensure the accuracy of all data at the first recording. Record - keepers need to be trained be familiar with the meanings and filling requirements of various indicators and ensure the consistency and standardization of records. When filling use a black - ink pen with clear handwriting. No erasures are allowed. If there are errors cross them out with two lines sign and indicate the date. Electronic Data Capture (EDC) System Selection: This study manages data based on the EDC platform which supports the electronic collection and management of data from paper - based case report forms improving the efficiency and accuracy of data processing. Data Collection Functions Data Entry: Data will be entered into the electronic data collection system independently by two people. The entry personnel need to operate strictly in accordance with the content of the CRF. During the entry process the system conducts real - time verification of data formats and logical relationships. For example the age must be a positive integer and all scores must be within a reasonable range etc. to ensure the accuracy of the entered data and reduce input errors. Data Verification: After the entry is completed the system automatically cross - checks the data entered by the two people. If inconsistent data is found the system automatically marks it and generates a data query which is sent to relevant researchers for verification and processing. Data Management Functions Data Query Handling: For inconsistent or doubtful data the system promptly sends data queries to the research sites. After receiving the queries researchers need to provide explanations or corrections within a specified time. The relevant handling processes and results are recorded in detail in the system to ensure the accuracy and integrity of the data. Data Review: Regular data review meetings are held. The integrity and accuracy of the data are examined through the system. Reviewers can use the query and statistical functions of the system to check for data missing situations outliers and other issues and resolve any unresolved data problems. Data Locking: Once all data problems are resolved and confirmed by the research director the database will be locked to prevent unauthorized subsequent changes and ensure that the integrity of the data is not affected. Data Backup: The system regularly backs up data at preset time intervals (such as daily or weekly). The backup data is stored on multiple media (such as disk arrays and tape libraries) and saved in different locations to prevent data loss or damage. Data Confidentiality: Through technical means such as user - rights management encrypted data transmission and storage the confidentiality of all research data is ensured. Only authorized researchers can access data with corresponding rights by logging into the system with their respective accounts and passwords. Data Reporting: After the study is completed the system can generate a detailed data management report summarizing the data collection processing and cleaning processes. The report content includes the types and quantities of data entry errors data query handling situations data missing situations etc. providing support for the analysis and evaluation of research results.

数据管理委员会：

Data Managemen Committee：

有

Yes

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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