Yang 2020.
| Study name | The efficacy and safety of Ginkgo biloba dropping pills in the treatment of coronary heart disease with stable angina pectoris and depression |
| Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: 72 Length of follow‐up: no follow‐up Analysis: not specified |
| Participants | Location: China Number of study centres and setting: not specified, affiliated with Foshan Chancheng Central Hospital (Guangdong), The First Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong), Luohu District People's Hospital (Guangdong), and The Second Affiliated Hospital of Guizhou University of Chinese Medicine (Guizhou) CAD criteria: coronary heart disease and at least 1 of (history of myocardial infarction; coronary artery revascularisation; coronary radiography or coronary angiography with at least 1 coronary artery stenosis and lumen stenosis ≥ 50%; or cardiac magnetic resonance imaging or radionuclide myocardial perfusion imaging or cardiac color Doppler diagnosis coronary heart disease with myocardial ischaemia); stable angina pectoris treated for at least 4 weeks Depression criteria: diagnostic criteria for depressive episode in the ICD‐10 (World Health Organization) Other entry criteria: 18 to 75 years of age, informed consent, not used any food that has an impact on intestinal flora such as foods containing probiotics (e.g. yogurt) or drugs (e.g. antibiotics) in the past 7 days Exclusion criteria: acute myocardial events, unstable angina pectoris, severe heart failure; serious arrhythmia; severe or poorly controlled hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg); sitting blood pressure and systolic blood pressure ≤ 85 mmHg or symptomatic hypotension, severe primary diseases such as liver, kidney, and haematopoietic system, or serious diseases affecting patient's survival (such as tumour, etc.); serious suicidal tendency (HAM‐D item 3 ≥ 3); bipolar disorder depressive episode in patients with epilepsy history, or depression secondary to other mental or physical diseases; alcohol and drug dependence within 1 year; abnormal liver and kidney function (ALT and/or AST > 3 times of the upper normal limit, and/or CRE > 2 times of the upper normal limit); patients who are currently taking antianxiety drugs; pregnant women, lactating women, women of child‐bearing age who do not take effective contraceptive measures, or who plan to conceive during the trial, and whose pregnancy test results are positive before the test; those who have participated in clinical trials of other new drugs within 30 days before screening; other reasons unsuitable to participate (researcher determined); allergic to the ingredients contained in Ginkgo biloba dropping pills |
| Interventions | Intervention: sertraline 50 mg/d with weekly dose 150 to 200 mg per week Ginkgo biloba dropping 63 mg x 5 pills, x 3 per day (total 945 mg/d) Control: matching placebo, not further specified |
| Outcomes | Primary:
Secondary:
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| Starting date | 20 September 2020 |
| Contact information | Zhongqi Yang T: 0086‐020‐36591222 E: Yang_zhongqi@163.com |
| Notes |
BDI: Beck Depression Inventory BDNF: brain‐derived neurotrophic factor CABG: coronary artery bypass graft CAD: coronary artery disease CBT: cognitive‐behavioural therapy CHD: coronary heart disease DSM‐5: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition HADS: Hospital Anxiety and Depression Scale HAM‐D: Hamilton Depression Rating Scale ICD: International Classification of Diseases ITT: intention to treat NYHA: New York Heart Association PCI: percutaneous coronary intervention PHQ‐9: Patient Health Questionnaire PROMIS: Patient‐Reported Outcomes Measurement Information System RCT: randomised controlled trial SSRI: selective serotonin reuptake inhibitor TCM: Traditional Chinese Medicine