KCT0004823进行中（未招募）未知
The effect of red ginseng on the metabolic syndrome by adjustmenting gut microbiota: a randomized, double-blind, placebo-controlled clinical trial
Dongguk University Ilsan Oriental Hospital0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •Prior to participation in the study, the purpose and contents of the research, the characteristics of the test food (red ginseng capsules) and the control food (placebo capsules) were thoroughly explained to the participants. As an adult with written consent, a person who meets the conditions described below is selected.
- •- inclusion criteria
- •1) a person aged 19 to 65
- •2) A person including 3 or more of the following metabolic syndrome factors
- •? Waist circumference (WC) Male> 90cm, Female> 85cm
- •? Triglyceride (TG) = 150 mg / dL or those taking medication for hyperlipidemia
- •? High density lipoprotein cholesterol (HDL-C) Male <40, Female <50 mg / dL
- •? Fasting glucose = 100 mg / dL or those taking medication for diabetes mellitus
- •? systolic blood pressure (sBP) = 130 mmHg and / or diastolic blood pressure (dBP) = 85 mmHg or those taking medication for hypertension
- •(However, if there is a test result of triglyceride, high-density lipoprotein cholesterol and fasting blood glucose within 4 weeks from a reliable institution, the screening test result can be replaced.)
- •3) A person who has explained the outline of this human application test and signed the consent form of this test
排除标准
- •- exclusion criteria
- •1) Patients with endocrine diseases that may affect body weight such as hypothyroidism and Cushing's syndrome
- •2) Patients with heart disease (heart failure, angina pectoris, myocardial infarction)
- •3) Patients with malignant tumor or lung disease
- •4) Patients diagnosed with liver dysfunction (ALT, AST = 2.5 times normal upper limit)
- •5) patients with cholelithiasis
- •6) serum Cr> 2.0mg / dl
- •7) Patients with narrow angle glaucoma
- •8) Patients with a history of neurological or psychological significance or current illness (schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, anorexia nervosa, etc.)
- •9) Patients with a history of stroke or temporary ischemic heart attack
- •10) Patients with history of basic eating disorders such as anorexia nervosa or bulimia nervosa
- •11) Patients who have taken medication that can affect weight, such as appetite suppressants, laxatives (without prescription) or oral steroids, thyroid hormones, amphetamines, ciproheptadine, phenodiazine or drugs that affect absorption, metabolism, and excretion within the last three months,
- •12) Patients receiving central nervous system drugs or central weight loss agents
- •13) Patients receiving other prohibited treatments (insulin, antidepressant, antiserotonin, barbiturate, antipsychotics, drugs of abuse)
- •14) Patients with anatomical changes such as resection that are difficult to assess
- •15) Patients who have had surgery to lose weight: gastroplasty, etc.
- •16) Pregnant women, nursing mothers, women of childbearing potential who have plan for pregnant or who do not agree to the appropriate method of birth control (for example, oral contraceptives, hormonal transplants, IUDs, spermicide barrier methods, condoms, abstinence, etc.)
- •17) Patients who have taken other test drugs within the last month
- •18) Patients who lost more than 10% of their previous body weight within six months
- •19) Based on the findings of the clinical researcher, the patient may not be able to follow the test requirements.
- •20) Have taken antibiotics or probiotics within the last month
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