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Neuroimaging mechanism study of Xueshuan Xinmaining on cognitive impairment in patients with lacunar infarction

Registration number：

ITMCTR2100004894

Date of Last Refreshed on：

2021-05-28

Date of Registration：

2021-05-28

Registration Status：

Prospective registration

Public title：

Neuroimaging mechanism study of Xueshuan Xinmaining on cognitive impairment in patients with lacunar infarction

English Acronym：

Scientific title：

Neuroimaging mechanism study of Xueshuan Xinmaining on cognitive impairment in patients with lacunar infarction

Scientific title acronym：

Study subject ID：

P21003/PJ03

The registration number of the Partner Registry or other register：

ChiCTR2100046758 ; ChiMCTR2100004894

Applicant：

Wei Dongfeng

Study leader：

Wei Dongfeng

Applicant telephone：

+86 18301311686

Study leader's telephone：

+86 18301311686

Applicant Fax：

Study leader's fax：

Applicant E-mail：

weidongfeng@aliyun.com

Study leader's E-mail：

weidongfeng@aliyun.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

16 Nanxiao Street in Dongzhimen, Dongcheng District, Beijing

Study leader's address：

16 Nanxiao Street in Dongzhimen, Dongcheng District, Beijing

Applicant postcode：

100700

Study leader's postcode：

100700

Applicant's institution：

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Approved by ethic committee：

Approved No. of ethic committee：

P21003/PJ03

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Date of approved by ethic committee：

2021/5/17 0:00:00

Contact Name of the ethic committee：

Gu Hao

Contact Address of the ethic committee：

16 Nanxiao Street in Dongzhimen, Dongcheng District, Beijing

Contact phone of the ethic committee：

+86 10 64093247

Contact email of the ethic committee：

hebegu@126.com

Primary sponsor：

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Primary sponsor's address：

16 Nanxiao Street in Dongzhimen, Dongcheng District, Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Address：

16 Nanxiao Street in Dongzhimen, Dongcheng District

Source(s) of funding：

National Natural Science Foundation of China

Target disease：

Lacunar infarction

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Post-marketing clinical trial

Objectives of Study：

Based on the theory of ''Blood Vessel Treatment'', to observe the cognitive improvement effects of Xueshuan Xinmaining tablets on patients with lacunar infarction, and illustrate the neurological mechanisms of drug action.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Outpatients or inpatients aged 50-80 years and elderly residents of the community, education level >= 6 years; 2. There are objective lacunar infarcts detected by MRI, and the diameter of the lesion range from 215mm; 3. The score of Mini-Mental State Examination < 27, objective cognitive impairment; 4. No history or signs of stroke.

Exclusion criteria：

1. Patients with severe heart, liver, and renal insufficiency (Note: Severe liver insufficiency refers to ALT value > 2 times the upper limit of normal or AST value > 2 times the upper limit of normal; severe renal insufficiency refers to creatinine value > 1.5 times normal upper limit); 2. There is coagulopathy, systemic bleeding, a history of coagulopathy or systemic bleeding, a history of thrombocytopenia or neutropenia; 3. Patients with other mental and nervous system diseases and malignant tumors; 4. Those who have participated in other drug trials within 3 months before being selected; 5. Those who have poor compliance or are dying and cannot complete the course of treatment; 6. Use other drugs to improve cognitive function such as ChEIs or other psychotropic drugs in the past 3 months.

Study execute time：

From 2021-06-21

To      2022-09-30

Recruiting time：

From 2021-06-21

To      2021-09-20

Interventions：

66

Group：

Group 1

Sample size：

Intervention：

Xueshuan Xinmaining tablets

Intervention code：

34

Group：

Group 2

Sample size：

Intervention：

Ginkgo biloba capsules

Intervention code：

Total sample size ： 100

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Institution/hospital：

State Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal University

Level of the institution：

Country：

China

Province：

Beijing

City：

Institution/hospital：

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Level of the institution：

Country：

China

Province：

Beijing

City：

Institution/hospital：

Dongzhimen Hospital, Beijing University of Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Complex Figure Test

Type：

Primary indicator

Measure time point of outcome：

Base line, after six months

Measure method：

Scale measurement

Outcome：

Mean Diffusivity

Type：

Secondary indicator

Measure time point of outcome：

Base line, after six months

Measure method：

Magnetic resonance imaging

Outcome：

Verbal Fluency Test

Type：

Primary indicator

Measure time point of outcome：

Base line, after six months

Measure method：

Scale measurement

Outcome：

Digit Span Test

Type：

Primary indicator

Measure time point of outcome：

Base line, after six months

Measure method：

Scale measurement

Outcome：

Network Connections

Type：

Secondary indicator

Measure time point of outcome：

Base line, after six months

Measure method：

Magnetic resonance imaging

Outcome：

Mini-Mental State Examination

Type：

Primary indicator

Measure time point of outcome：

Base line, after six months

Measure method：

Scale measurement

Outcome：

Geriatric Depression Scale

Type：

Primary indicator

Measure time point of outcome：

Base line, after six months

Measure method：

Scale measurement

Outcome：

Full-Dimensional Cognitive Function Score

Type：

Primary indicator

Measure time point of outcome：

Base line, after six months

Measure method：

Cognitive scale

Outcome：

Fractional Anisotropy

Type：

Secondary indicator

Measure time point of outcome：

Base line, after six months

Measure method：

Magnetic resonance imaging

Outcome：

Trails Test

Type：

Primary indicator

Measure time point of outcome：

Base line, after six months

Measure method：

Scale measurement

Outcome：

Activities of Daily Living

Type：

Primary indicator

Measure time point of outcome：

Base line, after six months

Measure method：

Scale measurement

Outcome：

Stroop Colour-Word Test

Type：

Primary indicator

Measure time point of outcome：

Base line, after six months

Measure method：

Scale measurement

Outcome：

Auditory Verbal Learning Test

Type：

Primary indicator

Measure time point of outcome：

Base line, after six months

Measure method：

Scale measurement

Outcome：

Pittsburgh Sleep Quality Index

Type：

Primary indicator

Measure time point of outcome：

Base line，After six months

Measure method：

Scale measurement

Collecting sample(s)
from participants：

Sample Name：

Urine

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

Faeces

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

50
Min age years
80
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

The investigator used computer to generate random numbers table.

Blinding：

Double blind

IPD sharing：

Yes

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

Publication of scientific research articles

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

Case Record Form

Data Managemen Committee：

No

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

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