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A randomized double-blind placebo-controlled study of Tongsaimai tablet in the treatment of stable carotid atherosclerotic plaque

Registration number：

ITMCTR2024000888

Date of Last Refreshed on：

2024-12-29

Date of Registration：

2024-12-29

Registration Status：

Retrospective registration

Public title：

A randomized double-blind placebo-controlled study of Tongsaimai tablet in the treatment of stable carotid atherosclerotic plaque

English Acronym：

Scientific title：

A randomized double-blind placebo-controlled study of Tongsaimai tablet in the treatment of stable carotid atherosclerotic plaque

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

JingJiao

Study leader：

Wu Shengxian

Applicant telephone：

18962295533

Study leader's telephone：

010-84015528

Applicant Fax：

Study leader's fax：

Applicant E-mail：

zhuchangle0106@163.com

Study leader's E-mail：

wushx@sina.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No.58 Kangyuan Road Jiangning Industrial City Lianyungang Economic and Technological Development Zone Jiangsu Province

Study leader's address：

No.5 Dongzhimen Shipping Warehouse Dongcheng District Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Jiangsu Kangyuan Pharmaceutical Co. LTD

Approved by ethic committee：

Approved No. of ethic committee：

2024DZMEC-002-02

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Commit Dongzhimen Hospital Beijing University of Chinese Medicine

Date of approved by ethic committee：

2024/2/7 0:00:00

Contact Name of the ethic committee：

Han Xueting

Contact Address of the ethic committee：

No.5 Dongzhimen Shipping Warehouse Dongcheng District Beijing

Contact phone of the ethic committee：

010-84012709

Contact email of the ethic committee：

dzmk@163.net

Primary sponsor：

Dongzhimen Hospital Beijing University of Chinese Medicine

Primary sponsor's address：

No.5 Dongzhimen Shipping Warehouse Dongcheng District Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

Dongzhimen Hospital Beijing University of Chinese Medicine

Address：

No.5 Dongzhimen Shipping Warehouse Dongcheng District Beijing

Source(s) of funding：

Jiangsu Kangyuan Pharmaceutical Co. LTD

Target disease：

Stabilizing carotid atherosclerotic plaque

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Post-marketing clinical trial

Objectives of Study：

A randomized double-blind placebo parallel controlled clinical trial was conducted to evaluate the efficacy and safety of Tongsaimai tablet in stabilizing carotid atherosclerotic plaque and reducing serum hs-CRP levels.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1) Patients with a history of ischemic stroke and carotid atherosclerotic plaque formation confirmed by color Doppler ultrasound; 2) Echoless/hypoechoic/mixed echoic plaques or plaque surface is not smooth/fiber cap is not complete/blood flow is not full; 3) Age between 40 and 80 years old regardless of gender; 4) can adhere to long-term medication; 5) No recent use of anti-inflammatory drugs; 6) The patient gives informed consent and signs the informed consent.

Exclusion criteria：

1) Acute or subacute hemorrhage within the plaque; 2) Complete calcification and fibrosis of plaque; 3) MRI and contrast media contraindications (such as carrying pacemakers dentures stents etc.); 4) Active ulcer and bleeding tendency long-term use of anticoagulant drugs (such as warfarin); 5) Patients with severe arrhythmia atrial fibrillation and heart failure; 6) Have serious liver kidney hematopoietic system endocrine system respiratory system and other primary diseases liver function is more than 1.5 times higher than the upper limit of normal Cr is higher than the normal value; 7) Any other life-threatening or serious illness that cannot be completed within 6 months of treatment so as to affect the evaluation results; 8) Pregnant or lactating women women with a recent pregnancy plan; 9) People with allergies; 10) Other diseases or mental disorders that the investigator believes may limit evaluation of efficacy or patient follow-up; 11) Patients who have participated in clinical trials of other drugs within the last 4 weeks

Study execute time：

From 2023-11-18

To      2026-07-18

Recruiting time：

From 2024-03-18

To      2025-01-08

Interventions：

36

Group：

Control group

Sample size：

Intervention：

Tongsai Mai tablet placebo oral 6 tablets/time 3 times/day after meals with warm water to take.

Intervention code：

36

Group：

Experimental group

Sample size：

Intervention：

Tongsai Mai tablet oral 6 tablets/time 3 times/day after meals with warm water to take.

Intervention code：

Total sample size ： 72

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Institution/hospital：

Dongzhimen Hospital Beijing University of Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

IL-6

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

blood pressure

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Blood Sugar

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

IL-1β

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

TNF-a

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Blood proteomics

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Weight

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Intestinal flora in stool

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Blood lipid

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

hs-CRP

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The incidence of cerebrovascular events at 1 year follow-up

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

faeces

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

40
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 experimental scheme adopts block randomization method. With the help of SAS statistical software given a seed number 72 subjects (treatment group and control group) were generated Scheduling that is a list of treatment assignments corresponding to serial numbers 01 to 72 (i.e. a random coding table)

Blinding：

IPD sharing：

Yes

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

After the completion of the experiment, it will be published in the form of a paper. Medidata Clinical Cloud®; https://login.imedidata.com

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

In this study electronic data acquisition system (EDC) is used for data management. Medidata Clinical Cloud®; https://login.imedidata.com

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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