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The efficacy and safety of Dazhu Rhodiola injection in the treatment of coronary heart disease and angina pectoris: a randomized, open-label, multi-center real world clinical study

The efficacy and safety of Dazhu Rhodiola injection in the treatment of coronary heart disease and angina pectoris: a randomized, open-label, multi-center real world clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036213
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-11-27
Completion date
Unknown
Last updated
2020-09-21

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

Conditions

Patients with coronary heart disease and angina pectoris, patients with heart blood stasis based on TCM differentiation

Interventions

Experimental group:According to the requirements of ACC/AHA coronary heart disease angina pectoris diagnosis and treatment guidelines, he received antiplatelet therapy, statins and nitrates. Rhodiola
Control group:According to the ACC/AHA coronary heart disease angina pectoris diagnosis and treatment guidelines, he received antiplatelet therapy, statins and nitrates.

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with coronary heart disease and angina pectoris diagnosis; 2. Patients who are currently receiving standard treatment for coronary heart disease and angina pectoris; 3. The age is from 18 to 75 years old; 4. Patients with heart blood stasis syndrome differentiation; 5. Patients who voluntarily accept the drug and sign informed consent. The informed consent process is in accordance with the relevant provisions of GCP.

Exclusion criteria

Exclusion criteria: 1. Patients with grade IV cardiac function (see Annex 4: NYHA classification); or patients with high risk of angina pectoris; 2. Patients with uncontrolled grade III hypertension (systolic blood pressure >=180mmhg and / or diastolic blood pressure >=110mmhg), severe cardiopulmonary dysfunction, serious arrhythmia, serious primary diseases of liver, kidney and hematopoietic system, or patients with serious diseases (such as tumors) and mental patients that affect their survival. 3. Patients with a history of hemorrhagic disease or other hemorrhagic diseases (PLT < 100x10^9/L); 4. Patients with abnormal liver and renal function indexes (alt, AST, SCR exceeding the upper limit of normal reference range by 2 times); 5. Aspirin contraindication patients; 6. Allergic constitution, or those who are allergic to various drugs and foods, or patients who are known to be allergic to the research drug (including its ingredients); 7. Pregnant or preparing for pregnancy and lactation; 8. Patients who participated in other clinical studies in the past month; 9. Patients considered unsuitable for clinical trials by the researchers.

Design outcomes

Primary

MeasureTime frame
The incidence of major adverse cardiovascular events (major adverse cardiovascular events include cardiovascular death, non-fatal myocardial infarction, and revascularization);

Secondary

MeasureTime frame
TCM syndrome curative effect;Angina pectoris efficacy;

Countries

China

Contacts

Public ContactYang Zhongqi

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

YP0317@163.com+86 13688867618

Outcome results

None listed

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