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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Study on Qingtan Huayu Formula for Intervention in Patients with Unstable Angina after PCI for Coronary Heart Disease

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Study on Qingtan Huayu Formula for Intervention in Patients with Unstable Angina after PCI for Coronary Heart Disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002294
Enrollment
Unknown
Registered
2025-11-21
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

unstable angina

Interventions

experimental group:Qingtan Huayu Formula Granules: Take 2 bags twice daily (morning and evening), dissolved in warm water, for a 4-week treatment course
control group:Placebo Granules: Take 2 bags twice daily (morning and evening), dissolved in warm water, for a 4-week period

Sponsors

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1)Aged 18-79 years, regardless of sex;2) History of percutaneous coronary intervention (PCI) for coronary heart disease;3) Meeting diagnostic criteria for unstable angina per Western medicine standards;4) Diagnosed with phlegm-heat blood stasis syndrome (TCM pattern);5) Voluntarily accepting Chinese herbal ;ecoction therapy;6) No use of Chinese herbal pieces or proprietary Chinese medicines within the preceding 2 weeks;7) Provided written informed consent after full explanation of study objectives and procedu

Exclusion criteria

Exclusion criteria: 1) Life-threatening comorbidities: pulmonary embolism, acute heart failure, respiratory failure, acute cerebral hemorrhage, acute myocardial infarction, severe arrhythmia, cardiac systolic dysfunction (LVEF 2×ULN and/or creatinine >2×ULN);9) Declined to sign informed consent

Design outcomes

Primary

MeasureTime frame
Angina Symptom Score;

Secondary

MeasureTime frame
Seattle Angina Questionnaire;Score of traditional Chinese medicine syndrome scale;Overall Response Rate;Left Ventricular Ejection Fraction;Left Ventricular End-Diastolic Dimension;Triglycerides;Total Cholesterol;Low-Density Lipoprotein Cholesterol;C-reactive Protein;High-Sensitivity C-reactive Protein;Interleukin-6;High-Density Lipoprotein Cholesterol;Trimetlylamine oxide;

Countries

China

Contacts

Public ContactBi Yingfei

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

yingfei1981@163.com13920648942

Outcome results

None listed

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