A clinical trial of Bio-Germanium for the evaluation of efficacy on immune function enhancement and immune cell activatio
- Conditions
- Not Applicable
- Registration Number
- KCT0002726
- Lead Sponsor
- Yonsei University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 130
1) Healthy male and female volunteers between the ages of 25 to 75 years
2) Screening result for WBC counts in between 4,000 cells/ul and 8,000 cells/ul
3) Volunteers who have agreed to participate in the study and provided a written content by him/herself or through its legal representative
1) 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)
2) Those with uncontrolled hypertension (140/90mmHg or higher, measured after 10 minutes of resting)
3) Those with uncontrolled diabetes (fasting blood glucose levels greater than 126mg/dl or those starting diabetes medication within 3 months)
4) Those received vaccination within 3 months before screening
5) Those with blood AST(GOT) or ALT(GPT) levels greater than 120IU/L
6) Those with blood creatinine level greater than 2.4mg/dL for male and 1.8mg/dL for female
7) Those who have consumed within 2 weeks before screening or are currently consuming health supplements that can affect immune function
8) Those under the severe gastrointestinal symptoms such as heartburn, indigestion, and such
9) Those who are pregnant, breastfeeding or planning to become pregnant during this study
10) Those who are oversensitive or allergic to the investigational product
11) Those who plan to participate in other researches during this study
12) Those who participated in other researches within 4 weeks of the start of this study
13) Those who are deemed inappropriate by the researcher
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method WBC(White blood cell) Count;NK(Natural killer) cell activity;Immune related indicator (IFN-?, IL-2, 6, 12, TNF-a, IgG1, IgG2, IgM);Evaluation of improvement by the subjects themselves (Excellent, Good, Unchanged, Worsening, Very aggravated / 5 Step)
- Secondary Outcome Measures
Name Time Method Adverse reactions;Vital signs (blood pressure, pulse), weight;Body temperature;Clinical pathology examination (hematology, blood chemistry, urinalysis)