A Clinical Trial of Bio-Germanium for the Evaluation of Efficacy on Immune Function Enhancement and Immune Cell Activation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- WBC(White blood cell) Count
研究概览
简要总结
This study is a 8-week, randomized, double-blind, placebo-controlled clinical trial of Bio-Germanium for the evaluation of efficacy on immune function and immune cell activation.
详细描述
This study will evaluate Bio-Germanium's efficacy on immune function and immune cell activation in healthy volunteers by assessing improvements in certain immune indices (i.e. NK cell activity, WBC, IFN-γ, TNF-α, IgG1, IgG2, IgM, IL-2, 6, 12).
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
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteers between the ages of 25 to 75 years
- •Screening result for WBC counts in between 4,000 cells/ul and 8,000 cells/ul
- •Volunteers who have agreed to participate in the study and provided a written content by him/herself or through its legal representative
排除标准
- •Those under the treatment for clinically significant acute or chronic diseases in cardiovascular, immune, respiratory, liver, biliary, renal, urinary, nervous, musculoskeletal system as well as psychiatric, infectious, hematologic and neoplastic diseases (exceptions can be made under the discretion of the researcher)
- •Those with uncontrolled hypertension (140/90mmHg or higher, measured after 10 minutes of resting)
- •Those with uncontrolled diabetes (fasting blood glucose levels greater than 126mg/dl or those starting diabetes medication within 3 months)
- •Those received vaccination within 3 months before screening
- •Those with blood AST(GOT) or ALT(GPT) levels greater than 120IU/L
- •Those with blood creatinine level greater than 2.4mg/dL for male and 1.8mg/dL for female
- •Those who have consumed within 2 weeks before screening or are currently consuming health supplements that can affect immune function
- •Those under the severe gastrointestinal symptoms such as heartburn, indigestion, and such
- •Those who are pregnant, breastfeeding or planning to become pregnant during this study
- •Those who are oversensitive or allergic to the investigational product
- •Those who plan to participate in other researches during this study
- •Those who participated in other researches within 4 weeks of the start of this study
- •Those who are deemed inappropriate by the researcher
研究组 & 干预措施
Investigational Group- Bio-Germanium
- Ingredient: Bio-Germanium
- Type: HPMC capsule
- Weight: 300mg/capsule
- Directions: 2 capsules, twice a day (1.2g/day of Bio-Germanium)
- Duration of use: 8 weeks
干预措施: Investigational Product (Bio-Germanium) (Dietary Supplement)
Control Group - Placebo Product
- Ingredient: Corn starch
- Type: HPMC capsule
- Weight: 300mg/capsule
- Directions: 2 capsules, twice a day
- Duration of use: 8 weeks
干预措施: Control Group - Placebo Product (Dietary Supplement)
结局指标
主要结局
WBC(White blood cell) Count
时间窗: at 8 week
WBC(White blood cell) Count
NK(Natural killer) cell activity
时间窗: at 8 week
NK(Natural killer) cell activity
Immune related indicator (IFN-γ, IL-2, 6, 12, TNF-α, IgG1, IgG2, IgM)
时间窗: at 8 week
Immune related indicator (IFN-γ, IL-2, 6, 12, TNF-α, IgG1, IgG2, IgM)
Evaluation of improvement by the subjects themselves
时间窗: at 8 week
Evaluation of improvement by the subjects themselves (Excellent, Good, Unchanged, Worsening, Very aggravated / 5 Step)
次要结局
- Body temperature(at 8 week)
- Adverse reactions(at 8 week)
研究者
Jong Ho Lee
Professor, Principal Investigator
Yonsei University