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Study on the therapeutic effect of Yiqi Fumai injection (freeze-drying) on angina pectoris in coronary heart disease and its impact on gut microbiota

Study on the therapeutic effect of Yiqi Fumai injection (freeze-drying) on angina pectoris in coronary heart disease and its impact on gut microbiota

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092685
Enrollment
Unknown
Registered
2024-11-21
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

coronary atherosclerotic heart disease

Interventions

On the basis of conventional Western medicine treatment, the treatment group was treated with injection of Yiqi Fumai (freeze-drying). :NA
The control group received conventional Western medicine treatment. :NA

Sponsors

The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Meets the Western diagnostic criteria for unstable angina pectoris in coronary heart disease, with a severity of grade I-III angina pectoris; (2) Meets the traditional Chinese medicine diagnostic criteria for qi and yin deficiency syndrome in chest obstruction and heart pain disease; (3) Age >= 18 years old; (4) Voluntarily participate and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Traditional Chinese patent medicines and simple preparations or decoction pieces of traditional Chinese medicine that have similar effects to those of supplementing qi and restoring pulse for injection (freeze-drying); (2) Those who have a treatment course of less than 7 days and are unable to complete subsequent treatment or follow-up procedures; (3) Participants in other clinical trials; (4) The researcher determines that they cannot complete or are not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Composite endpoint incidence of major adverse cardiovascular events (MACE);Detect the structure, function, and diversity of gut microbiota in the sample.;Changes in gut microbiota structure in patients with unstable angina pectoris and coronary heart disease before and after intervention with injection of Yiqi Fumai (freeze-drying).;

Secondary

MeasureTime frame
Traditional Chinese Medicine Symptom Grading Score;CCS Class;seattle angina questionnaire;European Five Dimensional Health Scale;Electrocardiogram efficacy;Cardiac function assessment;Angina pectoris efficacy score;

Countries

China

Contacts

Public ContactYang Jianfei

The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine

yangjianfei119@163.com+86 131 1560 6366

Outcome results

None listed

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