NCT00383058已完成3 期
The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- (Percent) reduction of body mass index and body weight
研究概览
简要总结
The purpose of this study is to examine whether the extract of the green tea is effective on obese women.
详细描述
We conducted the pilot study in 2005. The initial findings showed the extract of green tea is benefit on obese women. The potential benefit include appetite lowing, lipid markers decreasing and regulating balance of obese related hormone peptides. So we designed this trial.
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
- Double
入排标准
- 年龄范围
- 16 Years 至 60 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 16-60 years old female
- •BMI>27㎞/m2
- •Signed informed consent
排除标准
- •Endocrine disease, e.g. thyroid disorder, pituitary disorder, and sex gland disorder.
- •Heart disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker.
- •Allergy and Immunology disease.
- •High aminotransferases ( Alanine, Aspartate >80 IU/L) or high serum Creatinine (>2.5 mg/dL)
- •Pregnant or lactating women.
- •Childbirth within 6 months.
- •Stroke or otherwise unable to exercise
- •Management for weight control within 3 months.
- •Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge.
结局指标
主要结局
(Percent) reduction of body mass index and body weight
次要结局
- leptin, adiponectin and ghrelin comparisons and analysis
- (Percent) reduction of: Glucose, cholesterol,LDL, HDL and triglyceride
研究者
研究点 (2)
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