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The efficacy and safety of HJ11 granules for NSTEMI(Heat Retention Blood Vessel Syndrome): a clinical exploratory trial

Registration number：

ITMCTR2100004863

Date of Last Refreshed on：

2021-02-04

Date of Registration：

2021-02-04

Registration Status：

Prospective registration

Public title：

The efficacy and safety of HJ11 granules for NSTEMI(Heat Retention Blood Vessel Syndrome): a clinical exploratory trial

English Acronym：

Scientific title：

Research on key generic technologies and application of community prevention and control of chronic diseases related to phlegm and blood stasis

Scientific title acronym：

Study subject ID：

2020001005585

The registration number of the Partner Registry or other register：

ChiCTR2100043057 ; ChiMCTR2100004863

Applicant：

Chen Chao

Study leader：

Hu Jingqing

Applicant telephone：

+86 15801021012

Study leader's telephone：

+86 13911546633

Applicant Fax：

Study leader's fax：

Applicant E-mail：

cchhxp@gmail.com

Study leader's E-mail：

gcp306@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

16 Dongzhimennei Nanxiao Street, Dongcheng District, Beijing, China

Study leader's address：

16 Dongzhimennei Nanxiao Street, Dongcheng District, Beijing, China

Applicant postcode：

100700

Study leader's postcode：

100700

Applicant's institution：

Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences

Approved by ethic committee：

Approved No. of ethic committee：

2020-KY-EC-011

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences

Date of approved by ethic committee：

2021/7/30 0:00:00

Contact Name of the ethic committee：

Jiang Lijie

Contact Address of the ethic committee：

16 Dongzhimennei Nanxiao Street, Dongcheng District, Beijing, China

Contact phone of the ethic committee：

+86 10 64089001

Contact email of the ethic committee：

jcsec@126.com

Primary sponsor：

Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences

Primary sponsor's address：

16 Dongzhimennei Nanxiao Street, Dongcheng District, Beijing, China

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences

Address：

16 Dongzhimennei Nanxiao Street, Dongcheng District

Source(s) of funding：

Foshan science and technology innovation project: the special project of pioneering and experimental science and technology in the field of traditional Chinese medicine

Target disease：

NSTEMI

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

The primary objective of the study is to investigate the efficacy and safety of HJ11 granules in addition to standard treatments for NSTEMI(Heat Retention Blood Vessel Syndrome).

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Aged 40-80 years, male or female; 2. The diagnostic criteria for unstable angina pectoris were confirmed by the researchers in the Guidelines for Rapid Emergency Diagnosis and Treatment of Acute Coronary Syndrome (2019) published by the Chinese Medical Doctor Association Emergency Physicians Branch in 2019. 3. Global Registry of Acute Coronary Events (GRACE) risk score 2.0(18) in-hospital models; the patients will be judged as low-risk or medium-risk or high-risk patients (GRACE score < 140) by the researchers. 4. According to the main symptoms in the Diagnosing Items of Heat Retention Blood Vessel Syndrome of Coronary Heart Disease developed by our research group, the patients were judged by the researchers to be the patients with hot crunch; 5. Signed the informed consent and volunteered to participate in the study.

Exclusion criteria：

1. Patients with congenital organic heart disease, severe myocardial disease and severe cardiopulmonary dysfunction; 2. Severe arrhythmias (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.) with hemodynamic changes; 3. Complicated with severe liver (ALT or AST > 1.5 times the upper limit of normal value), kidney (CR BBB>per limit of normal value) dysfunction or severe blood disease, or other serious diseases affecting survival; 4. Patients with poor hypertension control (systolic blood pressure >= 160mm Hg, and/or diastolic blood pressure >= 100mm Hg); 5. Patients with high blood risk, including patients with congenital bleeding diseases (such as hemophilia), thrombocytopenia (platelet count less than 30 x 10^9/L) or patients with platelet dysfunction, or patients with coagulation disorders whose PT/APTT is higher than the upper limit of normal value); 6. Patients with severe cognitive impairment or mental disorder, unable to complete the subject's knowledge, unable to cooperate with clinical treatment and evaluation; 7. Pregnant or lactating women, or patients who intend to have children during the study period; 8. Participated in or is participating in other clinical trials within the last three months; 9. Patients who need to take Gansui, Jingdaji, Haizao, Yuanhua and Lilu during medication period; 10. Patients unsuitable for inclusion or unsuitable for other reasons as determined by the researcher.

Study execute time：

From 2021-07-30

To      2022-07-30

Recruiting time：

From 2021-07-30

To      2022-07-30

Interventions：

30

Group：

Control Group

Sample size：

Intervention：

Standardized treatment + HJ11 granules

Intervention code：

30

Group：

Experimental group

Sample size：

Intervention：

Standardized treatment + HJ11 granules

Intervention code：

Total sample size ： 60

Countries of recruitment
and research settings：

Country：

China

Province：

Guangdong

City：

Foshan

Institution/hospital：

Guangdong Hospital of Integrated Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

Liaoning

City：

Shenyang

Institution/hospital：

The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

Jiangxi

City：

Nanchang

Institution/hospital：

Jiangxi Provincial Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

hs-CRP, IL-6, TNF-α

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Left ventricular ejection fraction

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Homocysteine, Hcy

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Nitroglycerin reduction rate

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Blood proteomics

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Whole blood gene chip detection

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Average angina attacks per day

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

The incidence of cardiovascular end outcomes during follow-up

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

D2 polymers

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Seattle angina questionnaire

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Fecal intestinal flora detection

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

CTnI, CKMB(For PCI surgery)

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

IL-1β, IL-8

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Blood metabolism

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Changes of ST ECG

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Urine metabolomics

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

faeces

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

Urine

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)：

Random Sequences was generated by statisticians using SAS software

Blinding：

The subjects, researchers, assessors and statisticians will all be blind to the treatment allocation.

IPD sharing：

Yes

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

The published paper.

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

CRF

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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