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

Phase 1

Recruiting

• Conditions: nstable Angina

• Registration Number: ITMCTR2100004376
• Lead Sponsor: Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Aged >= 40 and <= 80, 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 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. Congenital organic heart disease, severe myocardial disease and severe cardiopulmonary dysfunction;
2. Severe arrhythmias (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.) with haemodynamic changes;
3. Complicated with severe liver dysfunction (alanine transaminase [ALT] or aspartate transaminase [AST] > 2 times the upper limit of the normal value), kidney dysfunction (creatinine > upper limit of the normal value), severe blood disease, or other serious diseases affecting survival;
4. Poor hypertension control (systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg);
5. Patients with high bleeding risk, including patients with congenital bleeding diseases (such as haemophilia) or thrombocytopenia (platelet count less than 30 x 10^9/L), patients with platelet dysfunction, or patients with coagulation disorders;
6. Severe cognitive impairment or mental disorder, inability to complete the informed consent, inability to cooperate with the clinical treatments and evaluations;
7. Pregnant or lactating women or patients who intend to have children during the study period;
8. Current or past participation in other clinical trials (within the last three months);
9. Patients who need to take Chinese herbal medicine with the following ingredients: Gansui (Euphorbia kansui T. N. Liou ex T. R Wang), Jingdaji (Euphorbia pekinensis Rupr.), Haizao (Sargassum Pallidum (Turn.) C. Ag. Or Sargassum fusiforme (Harv.) Setch.), Yuanhua (Daphne genkwa Sieb.et Zucc.) and Lilu (Veratrum nigrum L.) during the treatment period;
10. Unsuitable for inclusion for other reasons as determined by the researcher.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Seattle angina questionnaire;

Secondary Outcome Measures

Name	Time	Method
The total effective rate of ECG ST segment and T wave changes;The rate of discontinuation of nitroglycerine;D2 polymers;The incidence of cardiovascular end outcomes during follow-up;CTn, CKMB (For PCI surgery);hs-CRP, IL-6, TNF-a;Average angina attacks per day;