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Efficacy and Safety of Jiannao Tongluo Granules in Cognitive Impairment After Cerebral Infarction: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Registration number：

ITMCTR2100004850

Date of Last Refreshed on：

2021-05-15

Date of Registration：

2021-05-15

Registration Status：

Prospective registration

Public title：

Efficacy and Safety of Jiannao Tongluo Granules in Cognitive Impairment After Cerebral Infarction: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial

English Acronym：

Scientific title：

Efficacy and Safety of Jiannao Tongluo Granules in Cognitive Impairment After Cerebral Infarction: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2100046378 ; ChiMCTR2100004850

Applicant：

Cao Yuzhuo

Study leader：

Xia Wenguang

Applicant telephone：

+86 15871790856

Study leader's telephone：

+86 13377897278

Applicant Fax：

Study leader's fax：

Applicant E-mail：

kfyxcyz@163.com

Study leader's E-mail：

docxwg@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

11 Lingjiaohu Road, Jianghan District, Wuhan, Hubei

Study leader's address：

11 Lingjiaohu Road, Jianghan District, Wuhan, Hubei

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Hubei Hospital of Integrated Traditional Chinese and Western Medicine

Approved by ethic committee：

Approved No. of ethic committee：

（2021）伦审第（研015）号

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Hubei Provincial Hospital of Integrated Chinese and Western Medicine

Date of approved by ethic committee：

2021/4/15 0:00:00

Contact Name of the ethic committee：

Zhang Zheng

Contact Address of the ethic committee：

11 Lingjiaohu Road, Jianghan District, Wuhan, Hubei

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Hubei Provincial Hospital of Integrated Chinese and Western Medicine

Primary sponsor's address：

11 Lingjiaohu Road, Jianghan District, Wuhan, Hubei

Secondary sponsor：

Country：

China

Province：

Hubei

City：

Wuhan

Institution
hospital：

Hubei Provincial Hospital of Integrated Chinese and Western Medicine

Address：

11 Lingjiaohu Road, Jianghan District

Source(s) of funding：

Science and technology department of Hubei province

Target disease：

Cerebral Infarction

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

To evaluate the clinical efficacy of Jiannao Tongluo Granules in cognitive impairment after cerebral infarction.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. It meets the diagnostic criteria of "cerebral infarction" and is confirmed by head CT or MRI; 2. Comply with the standard of TCM stroke-wind, phlegm and blood stasis syndrome; 3. In the recovery period (the course of illness is 2 weeks to 6 months) 4. Aged 40 to 75 years; 5. For the first time, the vital signs are stable, the consciousness is clear, and they can cooperate with the examination and treatment; 6. The subject has an education level of elementary school or above, and is capable of completing cognitive function assessment; 7. Montreal Cognitive Assessment Scale (MoCA) score <26 points; 8. Volunteer to participate in this study and sign an informed consent.

Exclusion criteria：

1. Patients with severe cardiovascular, cerebrovascular, liver, kidney, malignant tumors, hematological diseases, and mental illnesses; 2. Transient organic psychosis and other mental illnesses (such as depression, schizophrenia), or other mental disorders that meet the DSM-IV-R standards; 3. Those who have other diseases that affect the function of limbs, and those who have dysfunction of limbs caused by claudication, osteoarthritis, rheumatoid arthritis, gouty arthritis, etc. before treatment may affect nerve or functional examination; 4. Those who are allergic to test drug ingredients, or have a history of alcohol or drug abuse; 5. Women who are pregnant or breastfeeding, or have a pregnancy plan within the past 6 months, or who cannot use effective contraceptive measures (sterilization, long-term use of contraceptives/drugs, condoms, or removal of the vas deferens from their partners, etc.); 6. Participating in other clinical trials or participating in other drug clinical trials within 3 months; 7. Patients judged by the investigator to be unsuitable to participate in this trial.

Study execute time：

From 2021-05-15

To      2022-12-31

Recruiting time：

From 2021-05-15

To      2022-07-31

Interventions：

52

Group：

experimental group

Sample size：

Intervention：

Jiannao Tongluo Granules plus conventional rehabilitation treatment

Intervention code：

52

Group：

control group

Sample size：

Intervention：

Placebo plus conventional rehabilitation treatment

Intervention code：

Total sample size ： 104

Countries of recruitment
and research settings：

Country：

China

Province：

Hubei

City：

Wuhan

Institution/hospital：

Hubei Provincial Hospital of Integrated Chinese and Western Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

TCM symptom score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Montreal Cognitive Assessment (MoCA)

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

National Institute of Health Stroke Scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Modified Barthel Index, MBI

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

event-related potential-P300

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Modified Rankin Scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

40
Min age years
75
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

SPSS was used to generate random sequences.

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)：

ResMan, http://www.medresman.org.cn.

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

Collect record data through case record table and establish electronic database management data.

Data Managemen Committee：

Not yet

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

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