KCT0001008尚未招募未知
A 12 week, double-blind, randomized, placebo-controlled clinical trial for evaluation of the efficacy and safety of GM-T(Triticum aestivum L. extract) on reducing body weight and body fat of overweight subjects
GeneMatrix0 个研究点目标入组 90 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 60(Year)（—）
- 性别
- All
入选标准
- •? Subjects who agree the particpation in the trial and submit informed and consent before the beginning of the trial.
- •? Male and female subjects between 20-60years of age inclusive
- •? BMI of 25.0-29.9kg/m2
排除标准
- •1)The Patients with severe cerebrovascular disease(infarct, hemorrage), cardiac disease(angina, myocardiac infarct, heart failure, arrhythmias that require treatment) within recent 6 months. (If that patient's clinical status is stable, they can participate in the clinical trial according to investgator)
- •2)Subjects with systolicBP = 160 mmHg or diastolicBP = 100 mmHg.
- •3)Subjects with diabetes(use of hypoglycemic agent or insulin)or fasting blood glucose = 126 mg/dL or random blood glucose = 200 mg/dL.
- •4)TSH(Thyroid Stimulating Hormone) value =0.1uU/ml or =10 uU/ml
- •5)Serum creatinine = 2 times the upper limit of normal.
- •6)Serum AST(Aspartate aminotransferase)/ALT(Alanine aminotransferase) = 3 times the upper limit of normal.
- •7)Subjects who complain gastrointestinal symptoms such as heartburn, dyspepsia
- •8)The patient who take the medicine that can affect the state of weight change (uptake inhibitors, appetite suppressant, antiobesity-related health functional food / supplements, antipsychotics, beta blocker, hydragogue, contraceptives, steroid, and hormon)within recent 1 months.
- •9)Participation in commercial diet program within the 3 months prior to screening.
- •10)Participation in any clinical trial within the 1 months prior to screening.
- •11)Subjects who get hospitalization, medications or rehabilitation treatments for Alcohol disorders, cardiovascular disease, disorder of central nervous system.
- •12)Subjects with the musculoskeletal disorders or restricted physical activity.
- •13)Pregnant or possibility of pregnancy, or breast feeding mothers.
- •14)Allergy or hypersensitivity in the GM-T(Triticum aestivum L. extract)
- •15)Inappropriate person decided by investigator.
研究者
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