A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Blood Triglyceride
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes of Triglyceride
研究概览
简要总结
This study was conducted to investigate the effects of daily supplementation of Angelica gigas N. extract on improvement of Blood Triglyceride.
详细描述
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Angelica gigas N. extract or a placebo group. Fasting triglyceride profiles before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19-80 years with Triglyceride 130-200 mg/dL
排除标准
- •Lipid lowering agent within past 6 months
- •Severe cardiovascular disease(Mvocardial infarction, Stroke, etc)
- •Renal disease(Heredity hyperlipidemia, Acute/Chronic renal failure, Nephrotic syndrome, etc)
- •Cancer, Respiratory organ disease(Asthma, Chronic obstructive pulmonary disease)
- •Autoimmune disease
- •Diabetes mellitus
- •Allergic or hypersensitive to any of the ingredients in the test products
- •History of disease that could interfere with the test products or impede their absorption
- •Under antipsychotic drugs therapy within past 2 months
- •History of alcohol or substance abuse
- •Participation in any other clinical trials within past 2 months
- •Laboratory test by show the following results
- •aspartate aminotransferase, alanine aminotransferase > Reference range upper limit treble
- •Serum Creatinine > 2.0 mg/dl
- •Pregnancy or breast feeding
- •Not Contraception(except: Surgery for female infertility)
研究组 & 干预措施
Angelica gigas N. extract
capsules (2cap/d, 1,000mg/d) for 12 weeks.
干预措施: Angelica gigas N. extract (Dietary Supplement)
Placebo
Placebo for 12 weeks
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes of Triglyceride
时间窗: 12 weeks
Changes of triglyceride were assessed before and after the intervention
次要结局
- Changes of Lipid profile(12 weeks)
- Changes of Arteriosclerosis index(12 weeks)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital