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A 12 weeks, randomized, double-blinded, placebo-controlled study of KBH-HM01 to evaluate efficacy and safety on immune function

Status Approved

First Submitted Date

2020/12/09
Registered Date

2020/12/28
Last Updated Date

2020/12/09

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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	KCT0005707
Unique Protocol ID	SMJOH-2020-12
Public/Brief Title	A 12 weeks, randomized, double-blinded, placebo-controlled study of KBH-HM01 to evaluate efficacy and safety on immune function
Scientific Title	A 12 weeks, randomized, double-blinded, placebo-controlled study of KBH-HM01 to evaluate efficacy and safety on immune function
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
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	SMJOH-2020-12
Approval Date	2020-11-27
Institutional Review Board Name	Semyung University Jecheon Oriental Medicine Hospital Institutional Review Board, SMJOH IRB
Institutional Review Board Address	65, Semyeong-ro, Jecheon-si, Chungcheongbuk-do
Institutional Review Board Telephone	043-649-1815
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	Seon Mi Shin
Title	Professor
Telephone	+82-43-649-1901
Affiliation	Semyung University
Address	65, Semyeong-ro, Jecheon-si, Chungcheongbuk-do
Contact Person for Public Queries
Name	Seon Mi Shin
Title	Professor
Telephone	+82-43-649-1901
Affiliation	Semyung University
Address	65, Semyeong-ro, Jecheon-si, Chungcheongbuk-do
Contact Person for Updating Information
Name	Seon Mi Shin
Title	Professor
Telephone	+82-43-649-1901
Affiliation	Semyung University
Address	65, Semyeong-ro, Jecheon-si, Chungcheongbuk-do

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	Not yet recruiting
Date of First Enrollment	2021-01-01 Anticipated
Target Number of Participant	100
Primary Completion Date	2021-03-31 , Anticipated
Study Completion Date	2021-03-31 , Anticipated
Name of Study	Semyung University Oriental Medicine Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-01-01 ,

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	KolmarBNH
Organization Type	Others
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	KolmarBNH
Organization Type	Others

7. Study Summary

Study Summary Information
Lay Summary	This randomized, double-blinded, placebo-controlled clinical trial is designed to evaluate the efficacy and safety of KBH-HM01 in immune function in accordance with immune related biomarkers. The participants voluntarily visit the institution and sign up for their participation. if the participants meet inclusion criteria in the screening test, subject enrollment will be proceeded. Then, selected participants will be randomized and the members in these group will intake KBH-HM01 or placebo for 12 weeks. The purpose of this study is that the test group (KBH-HM01) is superior to the control group (Placebo) in immune related biomarkers including NK cell activity after 12 weeks of administration.

Study Summary Information

Lay Summary

This randomized, double-blinded, placebo-controlled clinical trial is designed to evaluate the efficacy and safety of KBH-HM01 in immune function in accordance with immune related biomarkers. The participants voluntarily visit the institution and sign up for their participation. if the participants meet inclusion criteria in the screening test, subject enrollment will be proceeded. Then, selected participants will be randomized and the members in these group will intake KBH-HM01 or placebo for 12 weeks. The purpose of this study is that the test group (KBH-HM01) is superior to the control group (Placebo) in immune related biomarkers including NK cell activity after 12 weeks of administration.

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	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Dietary Supplement
Intervention Description	- Experimental group 50 people / placebo group 50 people - 1 pouch per 1 time, 2 times a day - Administration for 12 weeks
Number of Arms	2
Arm 1	Arm Label Experimental group
	Target Number of Participant 50
	Arm Type Experimental
	Arm Description Experimental group intake 40g of KBH-HM01 before meals, b.i.d., for 12 weeks.
Arm 2	Arm Label Placebo group
	Target Number of Participant 50
	Arm Type Placebo comparator
	Arm Description Experimental group intake 40g of KBH-HM01 placebo before meals, b.i.d., for 12 weeks.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (D50-D89)Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism (D84.9)Immunodeficiency, unspecified Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 45Year~70Year
	Description 1. Male or female subjects aged from 45 to 70 years old. 2. Subjects who signed written informed consent voluntarily. 3. white blood cell (WBC) ranged from 4,000 to 6,000/μl. 4. Subjects suffered from upper respiratory tract infection or cold-related symptoms which have possibilities to cause upper respiratory tract infection more than two times in the past one year. (*Tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, rhinitis, etc.)
Exclusion Criteria	1. History or presence of sensitivity or allergic to drugs or functional food including Angelica gigas Nakai, Cnidium officinale Makino, Paeonia lactiflora Pallas 2. Immune-related diseases, such as liver diseases including active hepatitis, leukemia, inflammatory systemic diseases, metabolic syndrome, infectious diseases, autoimmune diseases, etc. 3. Dementia, brain tumors, hydrocephalus, or who have conducted or are undergoing hormone replacement therapy within the last 4 weeks. 4. Stroke, heart disease (cardiac failure, arrhythmia, myocardial infarction, using implantable defibrillator), malignant tumor, angle close glaucoma, uncontrolled hypertension (SBP 140mmHg or higher or DBP 90mmHg or higher), lung disease, respiratory disease. 5. Serum creatinine> 2.0 mg/dl, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) is more than 2.5 times the normal upper limit. 6. Insulin injection, FBS (fasting blood sugar) level is greater than 160 mg/dl even taking drugs to control blood sugar. 7. Any of the following below a) Platelet ≤100*103 b) WBC 4,000-10,000/ul 8. Taking oral steroids, hormones, etc. within the last 4 weeks or has taken drugs that affect the absorption, metabolism, and excretion of investigational product. 9. Took other investigational product or participated clinical trial medicines within the last 3 months 10. Surgical surgery within the last 6 months or receiving prohibited treatment within 4 weeks (medical food for enhanced immunity, herbal medicine, or medication for possible abuse). 11. Surgery that may affect the absorption of drugs, such as gastrointestinal dysfunction or gastrointestinal resection. 12. Thyroid disease (hypothyroid or hormonal abnormalities/hypothyroidism). 13. Neurological and mental disorders (depression, schizophrenia) and psychotherapy. 14. Surgery (including childbirth) or cancer patients within the last 6 months. 15. Drug addicts and subjects who have taken vaccine, immunosuppressants, nonsteroidal anti-inflammatory drugs, steroids, and antihistamines within the last 3 months. 16. Fertile woman who disagrees with the choice of pregnant women, breastfeeding women and appropriate contraceptive methods (oral contraceptives, hormone transplants, intrauterine instruments, condoms, and spermicide). 17. Immunosuppressive drugs or other immuno-improvement functional foods within the last 4 weeks. 18. Donated whole blood within the last 2 months or donated blood components within 4 weeks. 19. Taken antibiotics for more than 7 days. 20. Judged by the investigators to be inappropriate for the clinical trial
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	Efficacy
Outcome	NK cell avtivity
Timepoint	week 0 (before intake), week 12
Secondary Outcome(s) 1
Outcome	Cytokine (TNF-α, IFN-γ, IL-2, IL-6, IL-12)
Timepoint	week 0 (before intake), week 12
Secondary Outcome(s) 2
Outcome	NK cell, NK T cell count
Timepoint	week 0 (before intake), week 12
Secondary Outcome(s) 3
Outcome	CD4+/CD8+ ratio
Timepoint	week 0 (before intake), week 12
Secondary Outcome(s) 4
Outcome	lymphocyte count
Timepoint	week 0 (before intake), week 12
Secondary Outcome(s) 5
Outcome	POMS questionnaire scoring
Timepoint	week 0 (before intake), week 12

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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