ITMCTR2024000099尚未招募4 期
Clinical and Mechanism Study of Shugan Jieyu Capsule in intervention of ACS and Depression
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 75（—）
- 性别
- All
入选标准
- •1. Age range: 18-75 years old;
- •2. Diagnosed with ACS (Acute Coronary Syndrome) within 2-12 weeks post-diagnosis;
- •3. Score on the HAMD-17 (Hamilton Depression Rating Scale) is between 17 and 24, inclusive, and symptoms of depressive mood or decreased interest have been present continuously for more than 2 weeks;
- •4. The participant has provided informed consent, voluntarily participates in this study, and has signed the informed consent form personally.
- •1) Depressive mood: Experiencing feelings of depression almost every day and for most of the day, either subjectively reported (e.g., feeling sad, empty, hopeless) or observed by others (e.g., showing signs of crying).
- •2) Decreased interest: Almost every day and for most of the day, there is a significant reduction in interest or pleasure in all or nearly all activities (either self-reported or observed).
排除标准
- •1. Impaired liver or kidney function (ALT or AST levels above 1.5 times the ULN, Cr or BUN levels above the ULN);
- •2. Participants with severe hematological disorders, malignant tumors, or other major illnesses;
- •3. Participants with severe suicidal tendencies (suicidal tendency score =3 on item 3 of the HAMD-17);
- •4. Participants with a history of depression or severe psychiatric illness prior to ACS onset;
- •5. Participants with heart failure classified as NYHA III-IV, EF <35%, or requiring ongoing mechanical assist therapy;
- •6. Participants who have taken antidepressants for a long time or within the past 4 weeks;
- •7. Participants who have taken medications containing Acanthopanax or St. John's wort for a long time or within the past 4 weeks;
- •8. Pregnant or breastfeeding women, or those planning to become pregnant during the trial period;
- •9. Participants who have participated in or are currently participating in another clinical study within the last three months;
- •10. Patients with other autoimmune diseases, such as rheumatoid arthritis, ankylosing spondylitis, inflammatory bowel disease, etc.;
- •11. Patients who have had acute infections within the past 4 weeks, or show symptoms and signs such as fever, cough, shortness of breath, abnormal white blood cell counts;
- •12. Patients who have taken immunosuppressive drugs within the last three months;
- •13. Patients who are suspected or confirmed to be allergic to the investigational drug;
- •14. Patients with conditions unsuitable for cardiopulmonary exercise testing, such as acute rapid arrhythmias, pulmonary edema, severe aortic valve stenosis, severe anemia, etc.
研究者
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