KCT0002193尚未招募未知
Efficacy and Safety of Hanslim for Obesity : A double-blinded, randomized, multicenter, multi-dose, placebo-controlled clinical trial
Hanpoong Pharm & Foods0 个研究点目标入组 165 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 165
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. Males and females aged 19 to 65 years
- •2. Subjects who meet one of the following criteria
- •1) Obesity subjects with BMI(body mass index) more than 30kg/?
- •2) Obesity subjects with BMI(body mass index) 27~29.9kg/? who has one or more risk factors such as hypertension, diabetes, hyperlipidemia.
- •3. Subjects who agreed low-calorie diet during clinical trial period
- •4. Subjects who singed a consent from after providing explanation about characteristics of this clinical trial
排除标准
- •1. Endocrine disease which could affect weight such as hypothyroidism, Cushing's syndrome and so on.
- •2. Subjects with heart diseases (heart failure, angina pectoris, myocardial infarction), respiratory diseases (asthma, obstructive pulmonary disease), stroke or ischemic heart failure who were not able to participate in this study
- •3. Subjects with malignant tumors within the last 5 years
- •4. Subjects who has narrow angle glaucoma
- •5. Cholelithiasis
- •6. Resistant hypertension
- •7. Severe renal function impairment (serum creatine > 2.0 mg/dL)
- •8. Severe liver function impairment (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase = 2.5 times of upper limit of normal range)
- •9. Uncontrolled diabete with HbA1c more than 8%
- •10. Patients with a neurological or psychologically significant history of the disease or who are currently suffering from the disease (schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, hyperphagia etc.)
- •11. Subjects who have taken oral steroids with high doses (more than prednisolon 30mg per day or equivalent doses) or long times (more than 8 weeks)
- •12. Subjects who have taken ß-blocker or diuretic as drugs for hypertension , anorexiants, relievers(without preion), thyroid hormone, amphetamine, cyproheptadine, phenothiazine, contraceptive or female hormones within the last 3 months that can affect on weight.
- •13. Subjects who have taken other forbidden treatments(insulin, antidepressants, anti serotonin reuptake inhibitor, barbiturate, antipsychotics, drugs concerned with misuse)
- •14. Subjects who underwent anatomical change such as incision which makes it difficult to conduct physical measurements
- •15. Subjects who underwent surgeries for weight reduction(gastroplastia)
- •16. Pregnant women, breast feeder, women planning a pregnancy and those who do not agree to use adequate contraception such as oral contraceptives, hormone transplant, intrauterine device, spermicide, condom, celibacy.
- •17. Subjects who have lost more than 10% of body weight within the last 6 months
- •18. Cessation of smoking within the last 3 months or an irregular smoking habit
- •19. Subjects who are participating in other intervention studies or who have taken other investigational drugs within the last one month
- •20. Subjects who are judged to be unable to comply the study according to the findings of the clinical investigator
研究者
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