chronic coronary syndrome complicated with depression (qi deficiency and blood stasis syndrome)
Conditions
Interventions
Sponsors
The Eighth Affiliated Hospital of Sun Yat-sen University (Futian, Shenzhen)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 75; 2. Meet the diagnosis of chronic coronary syndrome; 3.7=Hamilton Depression Rating Scale-17=24, and symptoms of depressive mood or diminished interest have persisted for more than 2 weeks; 4. Have never taken antidepressant medications orally, or have previously taken such medications but have stopped using them for more than half a year; 5. Possess normal communication skills and literacy ability; 6. Patients who, after fully understanding the trial process, agree to participate in the clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with acute coronary syndrome within the past year; 2. Patients with a Hamilton Depression Rating Scale-17 score 24; 3. Patients with severe anxiety or diagnosed with other mental disorders (e.g., schizophrenia spectrum, severe personality disorders, bipolar affective disorders, etc.) other than depression; 4. Patients with severe mental health disorders and severe suicidal tendencies (.Hamilton Depression Rating Scale-17 Item 3 suicide ideation score =3), as their condition may significantly impact the accuracy of the study and patient safety; 5. Patients with liver or kidney dysfunction (Alanine Aminotransferase or Aspartate Aminotransferase >1.5 times Upper Limit of Normal, Creatinine, Blood Urea Nitrogen >Upper Limit of Normal); 6. Patients who have undergone major surgeries (e.g., cardiac surgery, neurosurgery) or have a history of significant trauma within the past year; 7. Patients who have undergone percutaneous coronary intervention within the past 3 months; 8. Patients with malignant tumors or a life expectancy <1 year; 9. Patients who have participated in or are currently participating in other clinical studies within the past 3 months; 10. Patients lacking the ability to independently complete assessment scales or currently receiving other treatments or antidepressant medications; 11. Participants with known intolerance or allergies to the components of the investigational drug used in this study. Note: Any participant meeting any of the above criteria will be considered ineligible for this clinical study and will be promptly excluded from the study population.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale 17-item version; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale-17 Depression Scale, 7-Factor;Generalized Anxiety Disorder-7;Seattle angina questionnaire and its scores across various dimensions;The MOS 36-item short-form health survey;Traditional Chinese Medicine syndrome scoring;hypothalamic-pituitary-adrenal;High-sensitivity C-reactive protein; | — |
Countries
China
Contacts
Public ContactXU DANPING
The Eighth Affiliated Hospital of Sun Yat-sen University (Futian, Shenzhen)
Outcome results
None listed