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A clinical trial of Bio-Germanium for the evaluation of efficacy on immune function enhancement and immune cell activation

Status Approved

First Submitted Date

2018/01/19
Registered Date

2018/03/09
Last Updated Date

2019/05/07

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002726
Unique Protocol ID	7001988-201712-HR-322
Public/Brief Title	A clinical trial of Bio-Germanium for the evaluation of efficacy on immune function enhancement and immune cell activation
Scientific Title	A clinical trial of Bio-Germanium for the evaluation of efficacy on immune function enhancement and immune cell activation
Acronym	GRT_Bio_Ge
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	7001988-201712-HR-322-02
Approval Date	2017-12-14
Institutional Review Board Name	Yonsei University Institutional Review Board
Institutional Review Board Address	IRB Office, 50, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea
Institutional Review Board Telephone	02-2123-5143
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	JongHo Lee
Title	Professor
Telephone	+82-2-2123-3122
Affiliation	Yonsei University
Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea
Contact Person for Public Queries
Name	JungMin Jo
Title	Ph.D
Telephone	+82-2-313-8854
Affiliation	Yonsei University
Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea
Contact Person for Updating Information
Name	JungMin Jo
Title	Ph.D
Telephone	+82-2-313-8854
Affiliation	Yonsei University
Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2018-01-02 Actual
Target Number of Participant	130
Primary Completion Date
Study Completion Date
Name of Study	Yonsei University
Recruitment Status	Completed
Date of First Enrollment	2018-01-02 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Geranti Pharmaceutical
Organization Type	Pharmaceutical Company
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Yonsei University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	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. 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).

Study Summary Information

Lay Summary

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.  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).

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Supportive Care
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Dietary Supplement
Intervention Description	Experimental Group - 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 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
Number of Arms	2
Arm 1	Arm Label Experimental Group - Investigational Product (Bio-Germanium)
	Target Number of Participant 65
	Arm Type Experimental
	Arm Description • 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
Arm 2	Arm Label Control Group - Placebo Product
	Target Number of Participant 65
	Arm Type Placebo comparator
	Arm Description • 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

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	Not Applicable-Etc Select disease classification - Not applicable
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 25Year~75Year
	Description 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
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	WBC(White blood cell) Count
Timepoint	Screening, 4 week, 8 week
Primary Outcome(s) 2
Outcome	NK(Natural killer) cell activity
Timepoint	0 week, 4 week, 8 week
Primary Outcome(s) 3
Outcome	Immune related indicator (IFN-γ, IL-2, 6, 12, TNF-α, IgG1, IgG2, IgM)
Timepoint	4 week, 8 week
Primary Outcome(s) 4
Outcome	Evaluation of improvement by the subjects themselves (Excellent, Good, Unchanged, Worsening, Very aggravated / 5 Step)
Timepoint	4 week, 8 week
Secondary Outcome(s) 1
Outcome	Adverse reactions
Timepoint	4 week, 8 week
Secondary Outcome(s) 2
Outcome	Vital signs (blood pressure, pulse), weight
Timepoint	Screening, 4 week, 8 week
Secondary Outcome(s) 3
Outcome	Body temperature
Timepoint	Screening, 0 week, 4 week, 8 week
Secondary Outcome(s) 4
Outcome	Clinical pathology examination (hematology, blood chemistry, urinalysis)
Timepoint	Screening, 8 week

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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