Post-PCI chest pain combined with anxiety and/or depression symptoms
Conditions
Interventions
Control group:Shugan Jieyu capsule placebo
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 77 Years
Inclusion criteria
Inclusion criteria: 1: Non-ischemic chest pain with a frequency of more than 2 attacks per week within 1 year after coronary intervention 2: Being in a state of depression and/or anxiety, meeting the diagnosis of mild to moderate depression and/or mild to moderate anxiety: PHQ-9 score (5 to 14 points) and GAD-7 score (5 to 14 points) 3: Patients aged 18 to 77 years, regardless of gender 4: No TCM or Chinese patent medicine with the same efficacy as the experimental drug was used, and no new or increased dose of anti-angina drugs (including beta-blockers, non-dihydropyridine calcium antagonists, excluding nitroglycerin tablets) were used in the original standard western medicine treatment for coronary heart disease. 5: Patients can complete the questionnaire independently, are willing to be followed up and sign the informed consent form
Exclusion criteria
Exclusion criteria: 1: Participants who are allergic to Shugan Jieyu capsules will be excluded. 2: Severe uncontrolled respiratory, digestive, renal, blood, infectious, immune, endocrine, bone and joint, tumor diseases, and chest pain caused by diseases of the above systems, or diseases that may pose a serious risk to the patient, with an expected survival period of less than 12 months 3: Ischemic chest pain: (1) Severe stenosis remains after previous coronary revascularization surgery; (2) Severe ST segment depression was previously observed during a grade 1 cardiopulmonary exercise testing; (3) Chest pain accompanied by significant ST-T dynamic changes and/or elevated myocardial injury markers on electrocardiogram; (4) Continuous severe angina (CCS grade IV) 4: Previous echocardiography revealed a left ventricular ejection fraction (LVEF) 3 times the upper limit of normal reference value); severe renal insufficiency (eGFR less than 15 mL/min/1.73m²); uncontrolled severe hypertension (systolic blood pressure>180mmHg, diastolic blood pressure>110mmHg); uncontrolled severe hyperglycemia (fasting venous or capillary blood glucose>200 mg/dl or 11.1mmol/L for more than two times within one month before participating in this study) 8: Participated in another clinical study or received randomization in this study within 2 weeks before enrollment 9: Women of childbearing age, pregnant or breastfeeding, or those who intend to have a baby within 1 year 10: Patients with a history of mental illness, severe depression, or suicidal tendencies; individuals who have abused or become dependent on psychotropic drugs, alcohol, etc., within the past 6 months. 11: Patients deemed unsuitable for this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seattle Angina Questionnaire(SAQ); | — |
Secondary
| Measure | Time frame |
|---|---|
| Short Form-36 Health Survey Quality of Life Scale(SF-36);Hamilton Anxiety Scale(HAMA);Hamilton Depression Rating Scale(HAMD);Autonomic nervous system function testing;Visual Analogue Scale(VAS);Chinese Medicine Criteria Score; | — |
Countries
China
Contacts
Public ContactWeihui Lu
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed