A Clinical Trial of Bio-Germanium for the Evaluation of Efficacy on Immune Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-10

Study Completion Date

2018-09-10

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Normal Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Investigational Product (Bio-Germanium)

Intervention Type DIETARY_SUPPLEMENT

* Ingredient: Bio-Germanium
* Type: HPMC capsule
* Weight: 300mg/capsule
* Directions: 2 capsules, twice a day (1.2g/day of Bio-Germanium)
* Storage: Room temperature (below 25℃)
* Duration of use: 8 weeks

Control Group - Placebo Product

* Ingredient: Corn starch
* Type: HPMC capsule
* Weight: 300mg/capsule
* Directions: 2 capsules, twice a day
* Duration of use: 8 weeks

Group Type PLACEBO_COMPARATOR

Control Group - Placebo Product

Intervention Type DIETARY_SUPPLEMENT

* Ingredient: Corn starch
* Type: HPMC capsule
* Weight: 300mg/capsule
* Directions: 2 capsules, twice a day
* Storage: Room temperature (below 25℃)
* Duration of use: 8 weeks

Interventions

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Control Group - Placebo Product

* Ingredient: Corn starch
* Type: HPMC capsule
* Weight: 300mg/capsule
* Directions: 2 capsules, twice a day
* Storage: Room temperature (below 25℃)
* Duration of use: 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Investigational Product (Bio-Germanium)

* Ingredient: Bio-Germanium
* Type: HPMC capsule
* Weight: 300mg/capsule
* Directions: 2 capsules, twice a day (1.2g/day of Bio-Germanium)
* Storage: Room temperature (below 25℃)
* Duration of use: 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes