heart cardiovascular disease
Conditions
Interventions
Control group:Huoxue Jiedu Formula placebo + Western medicine basic treatment, one packet each time, bid.
Experimental group:Blood-activating and detoxifying formula + Western medicine basic treatment, 1 bag each time, twice daily.
Sponsors
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all the following criteria to be eligible for inclusion in this trial: (1) Coronary angiography or CTA demonstrating diffuse (length > 20 mm) lesions; (2) Diagnosis of stable angina pectoris in coronary artery disease; (3) NYHA functional class I–III; (4) At least one coronary stent implanted within 2 years post-PCI; (5) Age 18 years = age = 75 years; (6) Diagnosis of TCM stasis-toxin syndrome; (7) Informed consent obtained from the subject.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from this trial: (1) Severe renal impairment: serum creatinine >2.5 mg/dl (>220 µmol/l) in males or >2.0 mg/dl (>175 µmol/l); (2) Severe hepatic disease or ALT and AST levels both exceeding three times the upper limit of normal; (3) Controlled systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg; (4) Diabetes mellitus with random blood glucose =13.7 mmol/l or glycated haemoglobin =9.5%; (5) Pregnant women, women planning pregnancy, or breastfeeding women; (6) Patients with severe acute or chronic cerebrovascular disease; (7) Patients with malignant tumours; (8) Patients with severe haematopoietic system disorders; (9) Patients with severe psychiatric disorders; (10) Individuals with known hypersensitivity to any component of the study drug; (11) Participants who have enrolled in or are currently enrolled in another clinical trial within the preceding three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiopulmonary Exercise Test: Peak Metabolic Equivalent, Peak Oxygen Uptake per Kilogram; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiopulmonary exercise test: Oxygen threshold metabolic equivalents, Anaerobic threshold oxygen uptake per kilogram, Exercise duration, Power, Oxygen uptake, Heart rate, Oxygen pulse, Minute ventilation;Quality of life;Traditional Chinese Medicine Syndrome Scoring;Endpoint events and bleeding events; | — |
Countries
China
Contacts
Public ContactWang Peili
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed