KCT0007879进行中（未招募）未知
A randomized, double-blind, placebo comparative clinical trial to evaluate the functionality and safety of KPE01 and KPE02 for body fat reduction in overweight or obese adults.
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 150
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 59(Year)（—）
- 性别
- All
入选标准
- •1) Men and women between the ages of 19 and 60
- •2) Subjects with a body mass index (BMI) of 25 kg/m2 or more and less than 30 kg/m2
- •3) Subjects who consented to participate in this study and voluntarily signed a written consent form
排除标准
- •1) Subjects with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant tumor within the last 6 months (however, cerebrovascular disease, heart disease) Subjects who have a medical history but are clinically stable may participate in the trial at the discretion of the investigator.)
- •2) Drugs that affect body weight (fat absorption inhibitors and appetite suppressants, health food/supplements related to obesity, psychiatric drugs such as depression, beta blockers, diuretics, contraceptives, steroids, female hormones) within the last 1 month subject who is taking
- •3) Obese or overweight subjects due to endocrine diseases such as hypothyroidism and Cushing's syndrome
- •4) Subjects who are continuously receiving treatment or taking medications for gastrointestinal disorders (gastric ulcer, chronic digestive disorder, irritable bowel syndrome, etc.)
- •5) Subjects with a psychologically significant medical history or current disease (schizophrenia, epilepsy, anorexia, bulimia, etc.), or a history of alcohol and other drug abuse
- •6) Subjects judged to be unable to exercise due to musculoskeletal disorders
- •7) Fasting blood sugar of 126 mg/dl or more, random blood sugar of 200 mg/dl or more, or diabetic patients taking oral hypoglycemic agents or insulin
- •8) Patients with uncontrolled hypertension (blood pressure greater than 160/100 mmHg, measured after subject resting for 10 minutes)
- •9) Subjects whose AST(GOT) or ALT(GPT) is 2.5 times or more of the laboratory's upper limit of normal
- •10) Subjects with more than twice the upper limit of normal creatinine testing institute
- •11) Subjects who have lost 5% or more of weight within the last 3 months
- •12) Subjects who have participated in a commercial obesity program within the last 3 months
- •13) Subjects for whom 6 months have not elapsed since participating in the same trial
- •14) Subjects who are pregnant, lactating, or planning to become pregnant during the human application test period
- •15) Subjects who have an allergic reaction to food for human application testing
- •16) Subjects who are judged to be inappropriate as a researcher for other reasons
研究者
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