ISRCTN69953971已完成不适用
An explorative clinical trial to investigate the effects of Ginkgo biloba extract EGb 761® on arteriosclerosis-relevant biomarkers in men and women with early stage metabolic syndrome
Dr. Willmar Schwabe GmbH & Co. KG (Germany)0 个研究点目标入组 30 人开始时间: 2011年1月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- 性别
- All
入选标准
- •1. Male and female Caucasian subjects; females are eligible for enrolment if non-pregnant, non-lactating, having a negative pregnancy test at VI-01 and VI-02+, post-menopausal or using medically adequate contraception
- •2. Aged 21 to 50 years (boundaries included)
- •3. Lipoprotein(a) fraction: Lp(a) greater than 25 mg/dL at VI-01 and VI-02
- •4. Early stage metabolic syndrome - at least two but not more than three of the criteria listed below at VI-01 and VI-02:
- •4.1. Waist circumference greater than or equal to 102 cm in men, greater than or equal to 88 cm in women
- •4.2. Morning fasting triglyceride levels greater than or equal to 150 mg/dL (1.70 mmol/L)
- •4.3. Morning fasting high density lipoprotein (HDL)-cholesterol less than 40 mg/dL (1.04 mmol/L) in men, less than 50 mg/dL (1.30 mmol/L) in women
- •4.4. Recumbent systolic blood pressure (SBP) greater than or equal to 130 mmHg or diastolic blood pressure (DBP) greater than 85 mmHg
- •4.5. Morning fasting glucose greater than or equal to 100 mg/dL (5.55 mmol/L)
- •5. Absence of confounding co-morbidity
- •6. Absence of confounding co-medication
- •7. Willing and able to provide informed consent
- •8. Willing and able to comply with all procedures of the trial and attend all scheduled visits at the investigational site
排除标准
- •1. Previous participation in the trial
- •2. Participation in another clinical trial with a registered or non-registered drug or food supplement within the last 3 months prior to entry into the present study
- •3. Evidence or suspicion of hypersensitivity to the investigational drug
- •4. History or presence of treatment demanding allergies (including drug allergies)
- •5. Presence of acute or chronic infection at the time of recruitment
- •6. Evidence or suspicion of any relevant congenital disease or abnormality
- •7. Evidence or suspicion of any relevant clinical abnormality (as based on medical history, physical examination, vital signs, and 12-lead electrocardiogram [ECG])
- •8. Known gastrointestinal disorders (e.g. gastro-oesophageal reflux, partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhoea) within the last 6 months prior to inclusion into the study
- •9. Limiting vital signs, in particular:
- •9.1. Resting recumbent heart rate less than 50 or greater than 90 bpm
- •9.2. ECG: QTc greater than or equal to 450 msec (acc. Fridericia), QRS greater than or equal to 100 msec, PQ greater than or equal to 200 msec
- •9.3. Subjects with cardiac pacemaker or implantable cardioverter defibrillator
- •10. Relevant adverse clinical laboratory finding except for those explained and/or compatible with early-stage metabolic syndrome, in particular (but not exclusively) haemoglobin less than 13 g/dl for men and less than 12 g/dl for women; liver enzymes greater than 1.5 the upper limit of the normal range
- •11. Positive results for hepatitis and human immunodeficiency virus (HIV) serology
- •12. Positive alcohol or drug test
- •13. Use of prohibited medications, in particular medications for the treatment of hypertension, coronary heart disease, cardiac insufficiency, dysrhythmia, diabetes, hyper- or dyslipidaemia, anti-coagulants; such medications should not have been used within the two months before visit 1 and during the trial
- •14. Use (within the last two months before visit 1) of prohibited food supplements that might confound to the study criteria
- •15. Donation of blood or plasma within the last 30 days before visit 1
- •16. Evidence or suspicion that the subject is (socially) drug dependent, including those drinking more than 40 g alcohol per day
- •17. Smoking more than 10 cigarettes per day
- •18. Adherence to a prohibited diet (e.g. vegetarian) or lifestyle (including extreme physical activities such as competitive sports and weight lifting)
- •19. Evidence or suspicion that the subject might not be willing or able to comply with the study directives and restrictions, or that the subject might not be sufficiently reliable and trustworthy
- •20. Subjects who are known or suspected not to be capable of understanding and evaluation the information that is given to them as part of the obligatory information policy (informed consent), in particular regarding the risks and discomfort due to trial procedure to which they would agree to be exposed
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