KCT0005883招募中未知
A 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of TZ-HVP on decrement of body fat
Teazen0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 100
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
- 19(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1) Male or female subjects aged from 19 to 70 years old
- •2) BMI of 25 to <30 kg/m2
- •3) Satisfied with 1), 2) and subjects who decided to voluntarily participate in this clinical trial and complete to sign on the informed consent
排除标准
- •1) Participants with intentional weight loss of at least 10% within 3 months prior to screening
- •2) Subjects who have experience in influencing the interpretation of the results of this study, such as carbohydrates and lipid metabolism, drugs that can affect weight and hormones, or health functional foods within the last two months.
- •3) Subjects with acute severe cardiovascular disease such as heart failure, myocardial infarction, stroke, etc.
- •4) Subjects who in which the local or the systemic inflammatory immune disease including the rheumatoid arthritis, the autoimmune disease etc.
- •5) Subjects who have clinically significant hypersensitivity history due to drug, experimental product or ingredients
- •6) Subjects who have a medical history of gastrointestinal diseases(Crohn's disease, etc.) or operation(except appendectomy or herniotomy)
- •7) Participation in other clinical trials within the previous three months
- •8) Subjects with kidney disease, such as acute/chronic renal failure, nephrotic syndrome, etc
- •9) Subjects who has received antipsychotic treatment within two months before screening test
- •10) Subjects with reduced liver or kidney function
- •? AST, ALT > 3 times the upper limit of normal
- •? Creatinine = 2.0mg/dL
- •11) Subjects who are suspected drug abuse or have a medical history of dependent on drug
- •12) Subjects who are pregnant and breastfeeding female
- •13) Subject who do not perform adequate contraception in the urban eligible women (except woman who undergo sterilization operation)
- •14) Subject with hypersensitivity to the ingredients contained in a clinical product
- •15) Subject who takes diabetes and diabetes drugs
- •16) Uncontrolled hypertension (blood pressure = 160/100 mmHg)
- •17) Subject who deemed inappropriate to participate this clinical trial by research director due to other reasons including screening test
研究者
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