KCT0006619招募中未知
A 12 week, Multi-center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of PS01 on Reducing Body Fat
ovaKmed0 个研究点目标入组 120 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
- 120
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) Those who are 19 years old or older and 65 years old or younger
- •2) Those with body mass index (BMI) of 25 kg/m2 or more and less than 32 kg/m2 at Visit 1 and Visit 2
- •3) Those who have agreed to participate in this human application test before the start of the trial and who have filled out the Informed Consent Form.
排除标准
- •1) Those who are currently being treated for severe cardiovascular, immune, respiratory, hepatobiliary, renal and urinary, nervous, musculoskeletal, psychiatric, infectious diseases and malignant tumors, etc.
- •2) Those who have taken medications that affect body weight{obesity drugs(appetite suppressants, fat absorption inhibitors, GLP-1 receptor agonists, etc.),psychiatric drugs such as depression medication and schizophrenia medication, beta blockers, diuretics, contraceptives, steroids, female hormones}, health functional foods/supplements for weight control, herbal medicines, and formulas for weight control within 1 month (30 days) based on Visit 1
- •3) Patients with uncontrolled hypertension (systolic blood pressure of 160 mmHg or higher, diastolic blood pressure of 100 mmHg or higher, measured after stabilizing of 10 minutes)
- •4) Diabetic patients whose fasting blood sugar is 126 mg/dL or higher or who are taking antidiabetic drugs (oral hypoglycemic agents, insulin, etc.)
- •5) Those with TSH of 0.1 µIU/mL or less or 10 µIU/mL or more
- •6) Those whose creatinine is more than twice the normal upper limit of the testing institution
- •7) Those whose AST(GOT) or ALT(GPT) is 3 times or more of the normal upper limit of the testing institution
- •8) Those who have problems with food intake for human application test due to severe gastrointestinal disorders
- •9) Those with alcohol use-induced disorders and central nervous system disorders
- •10) Those who are judged unable to exercise due to musculoskeletal disorders
- •11) Those who had weight changes of 10% or more within 3 months based on visit 1
- •12) Those who participated in commercial obesity program within 3 months of visit 1
- •13) Those who have participated in other interventional clinical trials (including human application test) within one month (30 days) of Visit 1, or who are planning to participate in other interventional clinical trials (including human application test) after the start of this trial
- •14) Those who are pregnant, lactating, or planning to become pregnant during this trial period
- •15) Those who are sensitive or allergic to the food ingredients of this trial
- •16) Those who are judged to be inappropriate by the investigator for other reasons
研究者
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