NCT02428998已完成不适用
Safety Evaluation for 24 Weeks Intake of Korean Red Ginseng in Adults: A Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center, Exploratory Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- All adverse events occurring up to 24 weeks time after taking the Investigational product
研究概览
简要总结
Korean Red Ginseng appears to adverse events in adults taking 24 weeks Placebo and comparative assessment. And exploratory as Korean Red Ginseng blood sugar control, reduce body fat, URTI prevention, cardiovascular risk, renal function, cholesterol, improve, fatigue, and determine the impact on biological age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •19 years or older
- •agree to participate in this test, voluntarily signed by the parties to a written agreement
- •In the case of women of childbearing age and confirmed negative pregnancy test, you agree to contraception during the trial period applying human characters
排除标准
- •Pregnant and lactating mothers
- •Patients with a history of hypersensitivity to contain ingredients that caused the test food
- •patients with severe renal disease (serum creatinine levels greater than 1.5 times if the upper limit of normal
- •Patients with severe hepatic disease, such as cirrhosis (if AST or ALT greater than three times the upper limit of normal)
- •autoimmune diseases (multiple sclerosis, lupus, rheumatoid arthritis, etc.) patients with
- •patients with uncontrolled diabetes (for HbA1c 8.0% or more)
- •Sulphonylureas, diabetic patients being treated with Insulin
- •, uncontrolled hypertension (systolic blood pressure of 150mmHg or higher or if diastolic blood pressure greater than 100mmHg)
- •uncontrolled hyperlipidemia patients (if LDL-cholesterol is 160mg / dL or higher)
- •patients with uncontrolled thyroid dysfunction
- •patients with a dementia or psychiatric problems
- •treated with systemic steroid screening visit within 1 weeks ago
- •before the screening visit 4 weeks continuously for more than two weeks, the mentally ill and insomnia patients receiving antipsychotic medication within
- •taking the medicine within 4 weeks before the screening visit
- •taking the other investigational drugs or human test food application within four weeks before the screening visit
- •taking health supplements other than vitamins and minerals within 2 weeks before randomization
- •which means in other clinical care ∙ Psychiatric Disorders diseases, cardiovascular diseases, or gastrointestinal diseases, malignant tumors such as a medical condition that is likely to affect the test result is determined to be unfit to test patient participation
研究组 & 干预措施
Korean Red Ginseng
Experimental
Patients receive oral Korean Red Ginseng twice daily for 24 weeks. Treatment repeats every 4, 12, 24 weeks for 3 courses
干预措施: Korean Red Ginseng (Dietary Supplement)
Placebo
Placebo Comparator
Patients receive oral placebo twice daily for 24 weeks. Treatment repeats every 4, 12,24 weeks for 3 courses
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
All adverse events occurring up to 24 weeks time after taking the Investigational product
时间窗: up to 24 weeks time after taking the Investigational product
次要结局
- Adverse events that occurred up to 24 weeks to collect all focus point after taking the Investigational product(up to 24 weeks to collect all focus point after taking the Investigational product)
- Cardiovascular adverse events that occurred after taking the Investigational product(up to 24 weeks time after taking the Investigational product)
- Gastrointestinal adverse events that occurred after ingestion of Investigational product(up to 24 weeks time after taking the Investigational product)
- Neuropsychiatric adverse events that occurred after ingestion of Investigational product(up to 24 weeks time after taking the Investigational product)
- Grade 3 adverse events that occurred after ingestion of Investigational product(up to 24 weeks time after taking the Investigational product)
- Baseline by 24 weeks after the change in quality of life measures ingestion of Investigational product(up to 24 weeks time after taking the Investigational product)
研究者
研究点 (2)
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