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临床试验/NCT01625442
NCT01625442已完成4 期

Effect of Crocus Sativus (Saffron) and Berberis Vulgaris (Barberry Fruit) on Metabolic Syndrome

Birjand University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 732 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
732
试验地点
1
主要终点
Serum LDL cholesterol

研究概览

简要总结

The metabolic syndrome is associated with increased risk of cardiovascular disease and diabetes mellitus. The age-adjusted prevalence of the metabolic syndrome in the United States is 34% for men and 35% for women. Emerging alternative medicine worldwide led investigators to evaluate the efficacy of Crocus sativus (Saffron) and Berberis Vulgaris (barberry fruit) in treatment of metabolic syndrome. Serum total cholesterol, serum LDL cholesterol, serum HDL cholesterol, serum triglyceride, Fasting Blood Sugar and hematocrit measured before and after 45 days of treatment.

详细描述

In a randomized, placebo controlled, single-blind , efficacy trial with three treatment arms the investigators randomly assigned 105 patients with metabolic syndrome to receive barberry juice, saffron juice or placebo tablet.

The aim was to evaluate the efficacy of Crocus sativus (Saffron) and Berberis Vulgaris (barberry fruit) in treatment of metabolic syndrome. The metabolic syndrome (syndrome X, insulin resistance syndrome) consists of a constellation of metabolic abnormalities that confer increased risk of cardiovascular disease (CVD) and diabetes mellitus (DM). The major features of the metabolic syndrome include central obesity hypertriglyceridemia, low HDL cholesterol, hyperglycemia, and hypertension. Based on data from the National Health and Nutrition Examination Survey (NHANES) III, the age-adjusted prevalence of the metabolic syndrome in the United States is 34% for men and 35% for Women. Review of literature revealed anti-inflammatory, radical-scavenging, antioxidant, cytoprotective, beneficial cardiovascular and neural system effects for saffron, potential use for treatment of hypertension, tachycardia and some neuronal disorders, such as epilepsy and convulsion, antihypertensive and vasodilatory activities. Barberry has promising and selective anti-cancer activities, beneficial effects in atherosclerosis, arthritis, coronary heart disease and hepatitis, hypotensive property and to promote immunity, prevention of insulin resistance and related diseases, neuroprotective, hypolipidemic and antioxidant properties for saffron in animal models.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • waist circumference of ≥ 94 cm (males) or ≥ 80 cm (females) plus any two of the following:
  • blood pressure ≥ 130/85 or taking antihypertensive medication,
  • fasting plasma glucose (FPG) > 100 mg/dL,
  • serum triglycerides (TG) > 150 mg/dL,
  • high-density lipoprotein (HDL) < 40 mg/dL in men,and < 50 mg/dL in women-

排除标准

  • using insulin or glucose sensitizing medication
  • preexisting cardiovascular disease
  • psychiatric problems
  • non-compliance of patients
  • not presenting at times determined for treatment and evaluation

研究组 & 干预措施

Saffron

Active Comparator

Saffron treatment group received saffron tablets daily for 45 days

干预措施: Saffron tablet (Drug)

Barberry

Active Comparator

Barberry group received barberry tablets daily for 45 days

干预措施: Barberry tablet (Drug)

Placebo

Placebo Comparator

Placebo group received placebo tablets daily for 45 days

干预措施: Placebo (Drug)

结局指标

主要结局

Serum LDL cholesterol

时间窗: after 45 days of treatment

Serum LDL cholesterol after 45 days of treatment in three study groups

次要结局

  • Serum total cholesterol(after 45 days of treatment)
  • serum HDL cholesterol(after 45 days of treatment)
  • serum triglyceride(after 45 days of treatment)
  • Fasting Blood Sugar(after 45 days of treatment)
  • Hematocrit(after 45 days of treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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