KCT0004271招募中未知
A 16-week, randomized, double-blinded, placebo-controlled study of Peach blossom extract mixture (HT077) and Citrus extract mixture (HT048) to evaluate efficacy and safety on health subjects with overweight
EUMED0 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 59(Year)（—）
- 性别
- All
入选标准
- •1. Men and women aged =19 and <60 years
- •2. BMI of 25 to <30 kg/m2
- •3. Participants who voluntarily decide to participate and sign the informed consent after being provided an explanation of this trial.
排除标准
- •1. Participants with a history of hypersensitivity to drugs or food ingredients
- •2. Participants who have had participated in a commercial weight loss program or clinical trial for obesity within the last three months
- •3. Participants taking drugs or diet foods that affect their weight within 3 months prior to screening
- •4. Participants with intentional weight loss of at least 5% within 3 months prior to screening
- •5. Participants who have undergone surgery, such as gastroplasty and intestinal resection, to lose weight within 6 months prior to screening
- •6. Endocrine diseases such as hypothyroidism and Cushing's syndrome
- •7. Participants with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia in need of treatment), lung disease (chronic obstructive pulmonary disease, etc.) within the last 6 months (However, those who are clinically stable may participate in the trial at the investigator's discretion)
- •8. Serious dysfunction of the liver (alanine and aspartate aminotransferase levels of 2.5 times the upper limit or normal) or kidney (creatinine > 2.0 mg/dL)
- •9. Uncontrolled hypertension (blood pressure = 160/100 mmHg)
- •10. Fasting blood glucose = 126 mg/dL or random blood glucose = 200 mg/dL, or diabetic patients taking oral hypoglycemic agents or insulin
- •11. Malignant tumor diagnosed within 3 years prior to screening
- •12. Participants who complain of severe gastrointestinal symptoms such as heartburn and indigestion
- •13. Participants with a psychologically significant medical history or current disease (schizophrenia, epilepsy, anorexia, bulimia, etc.), or a history of alcohol or the other drug abuse
- •14. Participants who are determined to be unable to exercise due to musculoskeletal disorders
- •15. Pregnant or lactating participants, or women of childbearing age who do not agree to use contraception during the trial
- •16. Participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the investigator's opinion.
研究者
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