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Efficacy and safety of Tonifying Qi and Activating Blood Chinese herbal prescriptions for Myocardial Infarction: study protocol for a multi-centered RCT

Efficacy and safety of Tonifying Qi and Activating Blood Chinese herbal prescriptions for Myocardial Infarction: study protocol for a multi-centered RCT

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047435
Enrollment
Unknown
Registered
2021-06-18
Start date
2021-06-15
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Myocardial Infarction

Interventions

Sponsors

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnostic criteria of Western medicine for acute myocardial infarction and the etiological criteria of atherosclerotic type; 2. Patients who meet the TCM diagnostic criteria of qi deficiency and blood stasis syndrome in the recovery stage of myocardial infarction; 3. Patients who have successful reperfusion therapy for 2 weeks; 4. Subjects aged 18 to 80 years; 5. Subjects who signed informed consent, etc.

Exclusion criteria

Exclusion criteria: 1. For those patients with acut myocardial infarction Yin deficiency type; 2. Patients with severe liver or kidney insufficiency(ALT > 3 times of normal, SCR > 221 µ mol/L); 3. Patients with serious consumption state or malignant tumor, etc; 4. Pregnant or lactating women or those with pregnancy planning; 5. Suspected or definite allergy to test drug; 6. Participants in other clinical studies in recent 3 months; 7. Use any preparation containing the same ingredients within 2 weeks; 8. Patients who need continuous mechanical adjuvant therapy after successful interventional therapy.

Design outcomes

Primary

MeasureTime frame
Incidence of heart failure;Curative effect of Chinese Medicine Syndrome;Recurrence rate;All-cause mortality;Readmission rate due to cardiovascular events;Nonfatal stroke accidents;Non fatal myocardial infarction;Cardiovascular death;Curative effect of angina pectoris symptoms;Seattle Angina inventory;Six minute walk test;N-terminal precursor brain natriuretic peptide;Myocardial enzymes;Blood fat;Coagulation function test;Platelet aggregation rate;Cardiac ultrasound;Carotid ultrasound;Immune index;Inflammatory markers;Metabonomics;Liver function;Renal function;Blood routine examination;Routine urine examination;Routine stool examination;Electrocardiograph;Non-fatal cardiovascular events;Fatal cardiovascular events;Heart rate;Blood pressure;

Countries

China

Contacts

Public ContactShang Juju

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

shangjuju@bjzhongyi.com+86 13301132680

Outcome results

None listed

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