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A randomized controlled trial for qishen capsules in intervention of cardiovascular events after PCI for coronary heart disease

A randomized controlled trial for qishen capsules in intervention of cardiovascular events after PCI for coronary heart disease

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021058
Enrollment
Unknown
Registered
2019-01-27
Start date
2021-06-01
Completion date
Unknown
Last updated
2023-10-22

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

Conditions

Coronary heart disease (CHD)

Interventions

Group 1:Conventional western medicine treatment
Group 2:Conventional western medicine treatment+QiShen capsule

Sponsors

Fuwai Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Patients who were clearly diagnosed with coronary heart disease [5] and received elective PCI within two weeks after surgery; 3. It meets the syndrome differentiation standard of TCM qi deficiency and blood stasis [6]; 4. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects who have participated in other drug clinical trials or interventional studies within 30 days; 2. Serious arrhythmia, severe disorders of cardiopulmonary function (? heart function class, 4 severely abnormal lung function); 3. Patients with poor hypertension control (systolic blood pressure 160mmHg or diastolic blood pressure 100mmHg after treatment); 4. Patients with severe liver and kidney function impairment (ALT, AST or TBIL>2 times the upper limit of normal reference value, or Cr > 1.5 times the upper limit of normal reference value); 5. Patients with severe primary diseases or mental diseases such as hematopoietic system; 6. Allergic constitution or allergy to known components of the study drugs; 7. According to the judgment of the researcher, the subject is not suitable for study observation.

Design outcomes

Primary

MeasureTime frame
Cardiovascular related deaths;Nonfatal myocardial infarction;Revascularization;Nonfatal stroke;Number of readmissions and number of admissions due to angina within one year;

Secondary

MeasureTime frame
Number of readmissions due to cardiovascular events;Anginal frequency and angina pectoris score;Chinese medicine symptom complex score;Seattle angina scale score;PHQ-9?GAD-7scale;Echocardiography;NT-proBNP;Biochemical examination;Hs-CRP;

Countries

China

Contacts

Public ContactMa Lihong

Department of Traditional Chinese Medicine, Fuwai Hospital

mlh8168@163.com+86 10 5253 2174

Outcome results

None listed

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