KCT0007268招募中未知
A single-center, Randomized, Double-blind, Placebo-controlled, Intervention Study to evaluate Body Fat Reduction Efficacy and Safety of 'BN-202M' in Overweight Subjects
Hecto Healthcare0 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 60(Year)（—）
- 性别
- All
入选标准
- •1) A healthy male or female between the ages of 19 and 60
- •2) Subject with a BMI of 25kg/m2 or more and 29.9kg/m2 or less
- •3) Subject who voluntarily agreed in writing to participate in this human application test
排除标准
- •1) Subject who has a history of hypersensitivity to raw materials or natural products in this study
- •2) Subject whose weight gain or loss within 3 months is 5 kg or more
- •3) Subject with excessive alcohol consumption (> 20 g/day)
- •4) Subject who have been diagnosed with dyslipidemia (hyperlipidemia) and cannot stop taking drugs that can affect lipid changes (bile acids, sequestrants, fibrates, niacin, statins, and steroids for systemic action)
- •(However, selection is possible after a wash-out period of 2 weeks or more has elapsed, and the period may vary by drug.)
- •5) Subject who have been receiving continuous treatment or medication for more than 10 days due to gastrointestinal disorders (gastric ulcer, chronic digestive disorder, etc.)
- •6) Subject with uncontrolled hypertension (sitSBP = 160 mmHg or sitDBP = 95 mmHg) or those taking diuretics and beta-blockers among high blood pressure medications
- •7) Diabetic patients taking oral hypoglycemic agents or insulin
- •8) Subject who have experience in surgery such as satellite type or intestinal resection or other surgical operations to lose weight within 6 months prior to screening
- •9) Subject who have taken drugs (including herbal medicines or health functional foods) that can affect body weight within 3 months prior to screening
- •(obesity drugs including absorption inhibitors and appetite suppressants, antidepressants, antipsychotics, contraceptives and female hormones, thyroid hormones, amphetamines, phenodiazine, cyproheptadine, etc.)
- •10) Subject with uncontrolled hyperthyroidism or hypothyroidism (TSH less than 0.1uU/ml or more than 10uU/ml)
- •11) Subject with clinically significant hematological, cardiac (congestive heart failure, ischemic heart disease, etc.), lung, neurological disease, or other serious systemic disorders
- •12) Subject with clinically significant renal dysfunction (serum creatinine of 1.5 mg/dl or more) or chronic renal failure
- •13) Subject with clinically significant liver dysfunction (at least one of ALT, AST, and ?-GT is 2.5 times higher than the upper limit of normal), liver cirrhosis, or chronic liver disease
- •14) Subject with a history of malignancy within 5 years prior to screening
- •15) Subject with eating disorders, psychotic disorders including depression, drug addicts
- •16) Subject suffering from autoimmune diseases
- •17) Subject suffering from anemia/porphyria
- •18) Pregnant and lactating women and women of childbearing potential who do not use an appropriate method of contraception (but cannot take oral contraceptives)
- •19) Subject who have participated or plan to participate in other clinical (human application) trials within 3 months prior to screening
- •20) In the opinion of the person in charge of study, those who are judged not to be able to comply with the study requirements or to be inappropriate
研究者
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