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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043038
Enrollment
Unknown
Registered
2021-02-04
Start date
2021-07-30
Completion date
Unknown
Last updated
2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unstable Angina

Interventions

Sponsors

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

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Seattle angina questionnaire;

Secondary

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

Countries

China

Contacts

Public ContactHu Jingqing

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

gcp306@126.com+86 13911546633

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026