The efficacy and safety of HJ11 granules for NSTEMI(Heat Retention Blood Vessel Syndrome): a clinical exploratory trial
- Conditions
- STEMI
- Registration Number
- ITMCTR2100004863
- Lead Sponsor
- Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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.
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 & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method hs-CRP, IL-6, TNF-a;Nitroglycerin reduction rate;Average angina attacks per day;The incidence of cardiovascular end outcomes during follow-up;Seattle angina questionnaire;CTnI, CKMB(For PCI surgery);Changes of ST ECG;
- Secondary Outcome Measures
Name Time Method eft ventricular ejection fraction;Homocysteine, Hcy;D2 polymers;IL-1ß, IL-8;