angina pectoris
Conditions
Interventions
treatment group:LZHXF granules + Basic Western medical treatment
control group:LZHXF granules placebo+ Basic Western medical treatment
Sponsors
Xiyuan Hospital China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meets the criteria for complex coronary artery lesions with coronary angiography showing at least one of the following conditions: 1) Bifurcation lesions (collateral diameter > 2.0 mm); 2) Severe proximal vessel tortuosity; 3) Severe calcification; 4) Chronic total occlusion (>3 months); 5) Left main coronary artery lesions; 6) Aortic related opening lesions; 7) Diffuse lesions (length >20 mm); 8) Multivessel lesions (involving >2 vessels); 9) Severe angulated lesions (>90°); 10) In-stent restenosis; (2) Meets the diagnostic criteria for stable angina pectoris in coronary artery disease; (3) Angina attacks occur =2 times per week and =3 times per day; (4) NYHA functional class 1–3; (5) Patients who have refused surgical treatment for more than one year after coronary artery bypass grafting within two years or after acute coronary syndrome; (6) Age between 18 and 75 years; (7) Meets the diagnostic criteria for qi deficiency and blood stasis syndrome in traditional Chinese medicine; (8) Stable vital signs good cognitive and expressive abilities and able to undergo a cardiopulmonary exercise test and a six-minute walk test; (9) Informed consent obtained from the subject.
Exclusion criteria
Exclusion criteria: (1) Severe renal insufficiency: serum creatinine >2.5 mg/dL (>220 µmol/L) in males or >2.0 mg/dL (>175 µmol/L) in females; (2) Severe liver disease or ALT/AST levels exceeding 1.5 times the upper limit of normal (ULN); (3) Post-treatment systolic blood pressure (SBP) >160 mmHg or diastolic blood pressure (DBP) >100 mmHg; (4) Diabetes mellitus with random blood glucose =13.7 mmol/L or HbA1c =9.5%; (5) Pregnant or lactating women or women planning pregnancy; (6) Patients with severe acute/chronic cerebrovascular diseases; (7) Patients with malignancies; (8) Severe hematopoietic system disorders; (9) Severe psychiatric disorders; (10) Gastrointestinal disorders (e.g. peptic ulcer inflammatory bowel disease or malabsorption syndromes); (11) Participation in other clinical trials within the past 3 months or current participation; (12) Known hypersensitivity to the investigational drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Angina Pectoris Symptom Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Six-Minute Walk Test;Triglyceride;Hypersensitive C-reactive protein;Nitroglycerin withdrawal or reduction rateblood pressure;TCM syndrome score;High density lipoprotein cholesterol;Total Cholesterol;Interleukin- 6;Low-Density Lipoprotein Cholesterol;Tumor Necrosis Factor-a;Seatle Angina Questionnaire;Fatigue Severity Scale;Europe Quality of Life 5dimensions 5 levels;Cardiopulmonary exercise testing; | — |
Countries
China
Contacts
Public ContactQiuyan Li
Xiyuan Hospital China Academy of Chinese Medical Sciences
Outcome results
None listed