KCT0003754已完成未知
A randomized, double-blind, parallel, placebo-controlled clinical trial to evaluated the efficacy and safety of Perilla frutescens extract on decrement of body fat in overweight subjects
Wonkwang University, Gwangju Medical Center0 个研究点目标入组 80 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 80
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 65(Year)（—）
- 性别
- All
入选标准
- •(1) An adult male and female over the age of 19 and under 65 at the time of screening.
- •(2) Volunteers with a BMI of 25 to 29.9 kg / m2 at screening
- •(3) After fully hearing and understanding the details of this study, volunteers who have agreed to volunteer their participation
排除标准
- •(1) Those who have a BMI of 30 kg / m2 or more at the screening screening.
- •(2) Those who lost more than 10% of their weight within 3 months before the screening test.
- •(3) Those who have experience in taking medications or health-function foods that may affect research results such as diet pills and lipid degradation agents within four weeks prior to screening (However, they can participate after a four-week break before the first day of intake).
- •(4) Those with acute severe cardiovascular disease such as heart failure, myocardial infarction, and stroke.
- •(5) Those with immune-related disease or severe hepatic / renal failure or who have a history.
- •(6) Those with a history of clinically significant hypersensitivity reactions to drugs and health functional foods.
- •(7) Persons with a history of gastrointestinal disorders (eg, Crohn's disease) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of research products.
- •(8) Persons who have received antipsychotic medication within 2 months before screening.
- •(9) A person with a history of drug or alcohol abuse.
- •(10) Those who participated in other studies within 2 months before screening.
- •(11) Clinical pathologists who show the following results.
- •- AST, ALT> three times the upper limit of the reference range
- •- Serum Creatinine > 2.0 mg/dL
- •- Creatine Kinase(CK) > three times the upper limit of the reference range.
- •(12) Systolic blood pressure greater than 180 mmHg and relaxation pressure greater than 110 mmHg.
- •(13) A person diagnosed with diabetes.
- •(14) Postmenopausal women, postmenopausal hormone-taking women
- •(15) A pregnant or breast-feeding woman.
- •(16) Women who are pregnant and do not accept the appropriate contraceptive practice (except for women who have undergone sterilization).
- •(17) A person who is deemed unsuitable for participation in research due to the results of clinical pathology tests or other reasons.
研究者
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