Stable Coronary Artery Disease Complicated with Anxiety State
Conditions
Interventions
control group:Administer Simulated Granules of Xinyue Jieyu Formula and Conventional Western Medicine Treatment
Experimental Group:Administer Xinyue Jieyu Formula Granules and Conventional Western Medicine 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) Meet the diagnostic criteria for stable coronary heart disease (SCHD), with Canadian Cardiovascular Society (CCS) angina classification of Grade I or II; and confirmed by coronary computed tomography angiography (CTA) or coronary angiography to have stenosis of =50% in at least one coronary vessel, or a history of revascularization therapy, or a definite history of myocardial infarction. (2) Meet the diagnostic criteria for mild to moderate anxiety state. (3) Meet the diagnostic criteria for Xiongbi (Chest Bi Syndrome) of Qi Stagnation and Blood Stasis Syndrome. (4) Aged 30 to 75 years, with no gender restriction. (5) Volunteer to participate in the study and sign the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: (1) Patients with any of the following diseases: a. Patients with hypertension whose blood pressure remains elevated (systolic blood pressure = 180 mmHg, diastolic blood pressure = 100 mmHg) after treatment with antihypertensive drugs; b. Severe diseases such as severe malignant arrhythmias, cor pulmonale, rheumatic heart disease (RHD), myocarditis, cardiomyopathy, aortic dissection, and pulmonary embolism (PE). (2) Patients with chest pain symptoms associated with diseases including hyperthyroidism, cervical spondylosis, biliary-heart syndrome, hiatal hernia, neurosis, and menopausal syndrome. (3) Patients with a high risk of severe bleeding. (4) Patients with serum alanine aminotransferase (ALT) or serum creatinine (Scr) greater than 3 times the upper limit of the normal reference range (ULN). (5) Patients with severe hematological diseases and malignant tumors (cancers). (6) Patients complicated with severe infectious diseases, acute cerebrovascular disease, or other diseases, for whom investigators believe efficacy cannot be evaluated or it is unlikely to complete the expected treatment course and follow-up. (7) Patients with severe mental illness or a score of > 1 on the Columbia Suicide Severity Rating Scale (C-SSRS). (8) Patients who have participated in other clinical trials or taken oral Chinese herbal preparations of the qi-regulating and blood-invigorating type within the past 7 days. (9) Patients allergic to the study drug(s). (10) Pregnant women, women planning to become pregnant, or lactating women. (11) Patients who refuse to sign the informed consent form (ICF), or those with estimated poor compliance or low likelihood of follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale;Traditional Chinese Medicine (TCM) Syndrome Score Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Seattle Angina Questionnaire;Quality of Life Scale;Pittsburgh Sleep Quality Index;Incidence of Composite Endpoint Events;Levels of Inflammatory Factors;Thyroid Function;24-Hour Holter Electrocardiogram; | — |
Countries
China
Contacts
Public ContactZhang Dawu
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed