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Study on the efficacy and safety of Huoxue Bushen Anshen prescription in treating Qi deficiency and blood stasis and kidney deficiency syndrome after acute myocardial infarction

The clinical study of Huoxuebushen Anshen Granule treating the syndrome of kidney deficiency and blood stasis of heart failure after acute myocardial infarction

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074072
Enrollment
Unknown
Registered
2023-07-28
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-07-30

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

Conditions

Heart failure after acute myocardial infarction

Interventions

treatment group:On the basis of basic treatment, add Huoxuebushen Anshen prescription, take with warm water, one dose a day, once in the morning and once in the evening, 2 small bags/times, half an ho
control group:On the basis of basic treatment, add the simulation of Huoxuebushen Anshen prescription, take with warm water, one dose a day, once in the morning and once in the evening, 2 small bags/t

Sponsors

Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Age: 30-85 years old, male and female. (2) On the basis of meeting the Western diagnostic criteria for heart failure, 30% < left ventricular ejection fraction = 50% or NT-proBNP level =600 ng/L; (3) Those who meet the heart failure Qi deficiency and blood stasis and kidney deficiency syndrome; (4) Medical record requirements: chronic heart failure caused by myocardial infarction, at least 3 months of chronic heart failure clinical manifestations (patients in the early stage of heart failure, 3-6 months of diagnosis is appropriate); (5) The New York Heart Association (NYHA) has a heart function rating of II to III and has received optimal treatment at a fixed dose for at least 2 weeks; (6) Voluntarily participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with chest pain caused by other diseases, such as non-coronary heart disease, digestive system disease, chest wall disease, lung disease, somatic symptoms caused by mental disease, increased myocardial oxygen demand, such as high temperature, hyperthyroidism, hypertension, severe anemia, hypoxemia, etc.; (2) Combined with other causes affecting ECG ST-T changes, such as pre-excitation syndrome, ventricular pacing rhythm, digitalis drug influence, electrolyte disturbance, etc.; (3) Patients with severe heart disease, severe cardiopulmonary insufficiency, and severe heart failure; (4) Patients with a history of cerebrovascular disease within 1 year before screening; (5) blood creatinine exceeds the upper limit of normal value or any item of ALT and AST exceeds the upper limit of normal value by 3 times; (6) Women during pregnancy or within half a year to prepare for pregnancy, breastfeeding women; (7) Persons with mental illness or cognitive disabilities; (8) Suspected or confirmed to have a history of alcohol addiction, drug abuse; (9) Participants who had participated in other clinical trials within 30 days before screening; (10) Participants considered unsuitable for this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Left ventricular end-systolic volume;Left ventricular end-diastolic volume;Left ventricular ejection fraction;

Secondary

MeasureTime frame
Plasma NT-proBNP;ST2 level;The six-minute walk test;NYHA cardiac function classification;TCM syndrome efficacy quantitative evaluation score;Minnesota Heart failure Quality of Life Questionnaire scores;Hamilton Anxiety and Depression Scale score;

Countries

China

Contacts

Public ContactWang Jie

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

20150141038@bucm.edu.cn+86 136 0124 0162

Outcome results

None listed

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