ISRCTN30768139已完成不适用
A randomized, double-blind study to evaluate the effect of pomegranate extract on carotid atherosclerosis in patients with carotid artery disease
POM Wonderful, LLC (USA)0 个研究点目标入组 200 人开始时间: 2012年7月3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
- 200
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. Adult subjects, 18 years old and above
- •2. Patients with carotid plaque, as measured by 3-D ultrasound, having a mean baseline plaque volume of 200 mm3 (minimum of 100 mm3 and maximum of 900 mm3)
- •3. Subjects must be willing to give written informed consent and able to adhere to dosing schedule, visit schedule and phone follow-up assessment.
- •4. Subjects? clinical laboratory tests (CBC, blood chemistries and urinalysis) must be within normal limits or clinically acceptable to the investigator.
- •5. Subjects must be free of any clinically significant disease that would interfere with the study evaluations.
- •6. Female subjects of childbearing potential must be using a medically accepted method of birth control prior to the first clinic visit and agree to continue its use during the study, or have been surgically sterilized (e.g. hysterectomy or tubal ligation). Females of childbearing potential should be counseled in the appropriate use of birth control while in this study.
- •7. Females who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study.
- •8. Female subjects of childbearing potential must have a negative serum pregnancy test (beta-hCG) at the first clinic visit.
- •9. Patients on cardiovascular medications will be allowed to enter the study provided that they are on a stable medication regimen for at least 6 weeks prior study entry and patients agree to remain on the same regimen for the duration of the study. Medications permitted include: lipid lowering drugs, antihypertensive drugs, multiple vitamins, beta-blockers, calcium-channel blockers, ACE inhibitors, nitrates, a-adrenergic blockers, thiazide diuretics, antiplatelet agents, or anticoagulants (e.g. warfarin)
- •10. Patients on a stable diet for at least 4 weeks prior entry into the study and willing to maintain this diet for the duration of the study.
排除标准
- •1. Female subjects who are pregnant, intend to become pregnant, or are nursing
- •2. Subjects, who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study
- •3. Individuals with a history of mental instability, drug or alcohol abuse or individuals who have been treated or are being treated for severe psychiatric illness that, in the opinion of the investigator, may interfere with optimal participation in the study
- •4. Excessive alcohol consumption (more than 2 glasses per day or 14 glasses per week) or history of alcohol or drug abuse within the past 2 years.
- •5. Disorders of the hematologic, digestive, or central nervous systems, including cerebrovascular disease and degenerative disease, that would limit study evaluation or participation
- •6. Known impairment of renal function (eGFR <50), dysproteinemia, nephrotic syndrome, or other renal disease
- •7. Active or chronic hepatobiliary or hepatic disease.
- •8. Patients with AST or ALT >2 x upper limit of the laboratory reference range
- •9. Patients who are known to have tested positive for human immunodeficiency virus (HIV)
- •10. Patients who are currently enrolled in another clinical drug study
- •11. Patients who have used any investigational drug within 30 days of the first clinic visit
- •12. Congestive heart failure NYHA Class III or IV
- •13. Uncontrolled cardiac arrhythmias within 3 months of study entry
- •14. Myocardial infarction or coronary bypass surgery or angioplasty within 3 months of study entry
- •15. Unstable or severe peripheral artery disease within 3 months of study entry
- •16. Unstable angina pectoris within 3 months of study entry
- •17. Type I or Type II diabetes mellitus that is poorly controlled (HbA1c > 9.0%) or newly diagnosed (within 3 months) or a change in antidiabetic pharmacotherapy [i.e. changes in dosage (with the exception of ± 10 units of insulin) or addition of new medication] within 3 months of screening or patients experiencing recent history of repeated hypoglycemia or unstable glycemic control.
- •18. Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins. Clinically euthyroid subjects on replacement doses of thyroid hormone are eligible for enrollment
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