NCT03828188已完成不适用
A 12-week, Randomized, Double-blind, Placebo-controlled 2x2 Cross-over Design Human Trial to Evaluate the Efficacy and Safety of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes of Fasting triglyceride
研究概览
简要总结
This study was conducted to investigate the effects of daily supplementation of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level.
详细描述
This study was a 12-week, randomized, double-blind, placebo-controlled 2x2 cross-over design human trial. 50 subjects which of 25 by group were randomly divided into Red Ginseng Concentrated Powder and a placebo group.(A total of 100 subjects completed the 2x2 cross-over study.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19-70 years with Triglyceride 120-200 mg/dL
排除标准
- •Lipid lowering agent within past 6 months
- •Those with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
- •Persons with significant hypersensitivity reactions to ginseng and red ginseng
- •Those with a history of gastrointestinal disorders (ex, Crohn's disease) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of a product for clinical trials
- •Those who have received antipsychotic medication within 2 months before screening
- •Those with a history of alcoholism or substance abuse
- •Those who participated in other clinical trials within 2 months before screening
- •Laboratory test by show the following results
- •Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit
- •Serum Creatinine > 2.0 mg/dL
- •Pregnancy or breast feeding
- •Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
- •Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
结局指标
主要结局
Changes of Fasting triglyceride
时间窗: 12 weeks
Changes of Fasting triglyceride was assessed before and after the intervention
次要结局
- Changes of Carnitine (Serum)(30 weeks)
- Changes of lipoprotein lipase(30 weeks)
- Changes of Lipid metabolism indices(30 weeks)
- Changes of Arteriosclerosis indices(30 weeks)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital
研究点 (2)
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