Jiannao tongluo granules for convalescent cerebral infarction: a randomized controlled, double-blind trial

Registration number:

ITMCTR2100005030

Date of Last Refreshed on:

2021-07-06

Date of Registration:

2021-07-06

Registration Status:

Prospective registration

Public title:

Jiannao tongluo granules for convalescent cerebral infarction: a randomized controlled, double-blind trial

English Acronym:

Scientific title:

Jiannao tongluo granules for convalescent cerebral infarction: a randomized controlled, double-blind trial

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2100048405 ; ChiMCTR2100005030

Applicant:

Li Zhengliang

Study leader:

Xia Wen'guang

Applicant telephone:

+86 17771435723

Study leader's telephone:

+86 13377897278

Applicant Fax:

Study leader's fax:

Applicant E-mail:

lizhengliang23@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:

430000

Study leader's postcode:

430000

Applicant's institution:

Xinhua Hospital Affiliated to Hubei University of Traditional Chinese Medicine/Hubei Provincial Hospital of Integrated Chinese and Western Medicine

Approved by ethic committee:

Approved No. of ethic committee:

(2021)伦审第(研006)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:

2021/3/15 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:

+86 27 65600806

Contact email of the ethic committee:

Primary sponsor:

Xinhua Hospital Affiliated to Hubei University of Traditional Chinese Medicine/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 observe the curative effect of Jiannao Tongluo Granules on convalescent cerebral infarction with wind-phlegm and blood stasis, and to explore the possible mechanism of action.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

1. Meet the diagnostic criteria of ''cerebral infarction'' and be confirmed by head CT or MRI examination; 2. Meet the standard of traditional Chinese medicine for stroke - wind-phlegm stasis syndrome; 3. In the recovery period (the course of the disease 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 the patient can cooperate with the examination and treatment; 6. Voluntarily participate in this study and sign the informed consent.

Exclusion criteria:

1. Patients with severe cardiovascular and cerebrovascular, liver, kidney, malignant tumors, blood system diseases, and mental diseases; 2. Severe disturbance of consciousness, dementia or certain diseases that affect the evaluation of curative effect, such as aphasia, audio-visual impairment; 3. Transient organic psychosis and other psychotic disorders (such as depression, schizophrenia), or other mental disorders that meet the DSM-IV-R criteria; 4. Patients with other diseases that affect the function of limb movement, and those with limb movement dysfunction caused by claudication, osteoarthritis, rheumatoid arthritis, gouty arthritis, etc., which may affect the nerve or functional examination before treatment; 5. Those who are allergic to the components of the test drug, or have a history of alcohol or drug abuse; 6. Patients who are pregnant or breastfeeding, or who plan to become pregnant within the past 6 months, or who cannot use effective contraceptive measures (sterilization, long-term use of contraceptives/dose, condoms, or partner removal of the vas deferens, etc.); 7. Those who are participating in other clinical trials or have participated in other drug clinical trials within 3 months; 8. Patients who are judged by the investigator to be unsuitable to participate in this trial.

Study execute time:

From 2021-07-05

To      2022-12-31

Recruiting time:

From 2021-07-05

To      1990-01-01

Interventions:

34

Group:

low dose group

Sample size:

Intervention:

Low dose of Jiannao Tongluo granules and conventional treatment

Intervention code:

34

Group:

high dose group

Sample size:

Intervention:

High dose of Jiannao Tongluo granules and conventional treatment

Intervention code:

34

Group:

control group

Sample size:

Intervention:

Placebo and conventional treatment

Intervention code:

Total sample size : 102

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:

National Institute of Health Stroke Scale Score

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

Modified Rankin Scale Grading

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Fugl-Meyer Assessment Scale Score

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:

Montreal Cognitive Assessment (MoCA) Score

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Sample Name:

Null

Tissue:

Fate of sample 

Others

Note:

Not yet 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):

SAS was used to generate random sequences

Blinding:

Not stated

IPD sharing:

Yes

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

www.medresman.org

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above