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A 12 week, multi-center, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of BRB-F on improving liver function

Status Approved

First Submitted Date

2015/08/07
Registered Date

2016/11/17
Last Updated Date

2016/11/15

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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	KCT0002143
Unique Protocol ID	AS15042
Public/Brief Title	clinical trial for the evaluation of the efficacy and safety of BRB-F on improving liver function
Scientific Title	A 12 week, multi-center, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of BRB-F on improving liver function
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	AS15042
Approval Date	2015-06-09
Institutional Review Board Name	Korea University Ansan Hospital Institutional Review Board
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee	No

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	Do Hoon Kim
Title	MD, PhD
Telephone	+82-31-412-5360
Affiliation	Korea University Ansan Hospital
Address	Jeokgeum-ro 123, Danwon-gu, Ansan-si 15355, Republic of Korea
Contact Person for Public Queries
Name	Minjung Kim
Title	CRC
Telephone	+82-31-412-5360
Affiliation	Korea University Ansan Hospital
Address	Jeokgeum-ro 123, Danwon-gu, Ansan-si 15355, Republic of Korea
Contact Person for Updating Information
Name	Minjung Kim
Title	CRC
Telephone	+82-31-412-5360
Affiliation	Korea University Ansan Hospital
Address	Jeokgeum-ro 123, Danwon-gu, Ansan-si 15355, 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	Multi-center Number of center : 2
Overall Recruitment Status	Recruiting
Date of First Enrollment	2015-09-01 Actual
Target Number of Participant	80
Primary Completion Date
Study Completion Date
Name of Study	Korea University Ansan Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2015-09-01 ,
Recruitment Status by Participating Study Site 2
Name of Study	Korea University Anam Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2015-09-01 ,

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	Ministry of Agriculture, Food and Rural Affairs
Organization Type	Government
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	STR Biotech
Organization Type	Pharmaceutical Company

7. Study Summary

Study Summary Information
Lay Summary	A 12 week, multi-center, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of black rice bran-fermentation (BRB-F) on improving liver function

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	Prevention
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Dietary Supplement
Intervention Description	A 12 week, multi-center, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of BRB-F on improving liver function Experimental group: 1) older than 20 years and below 75 years, 2) During the past one month in the drinking lifestyle survey, more than the average male in a week 14 unit, female in a week 7 unit, 3) abnormal serum AST(GOT) or ALT(GPT) level and below 3-fold and γ-GTP level and below 4-fold of normal range, 4) individuals agreed to participate in the study voluntarily after sufficient explanation regarding the purpose and content of study Intervention: Twice a day, 3 capsules, with the water intake at the same time (600mg/day as BRB-F), for 12 weeks Placebo group: 1) older than 20 years and below 75 years, 2) During the past one month in the drinking lifestyle survey, more than the average male in a week 14 unit, female in a week 7 unit, 3) abnormal serum AST(GOT) or ALT(GPT) level and below 3-fold and γ-GTP level and below 4-fold of normal range, 4) individuals agreed to participate in the study voluntarily after sufficient explanation regarding the purpose and content of study Intervention: Twice a day, 3 placebo capsules, with the water intake at the same time, for 12 weeks
Number of Arms	2
Arm 1	Arm Label BRB-F
	Target Number of Participant 40
	Arm Type Experimental
	Arm Description Experimental group: 1) older than 20 years and below 75 years, 2) During the past one month in the drinking lifestyle survey, more than the average male in a week 14 unit, female in a week 7 unit, 3) abnormal serum AST(GOT) or ALT(GPT) level and below 3-fold and γ-GTP level and below 4-fold of normal range, 4) individuals agreed to participate in the study voluntarily after sufficient explanation regarding the purpose and content of study Intervention: Twice a day, 3 capsules, with the water intake at the same time (600mg/day as BRB-F), for 12 weeks
Arm 2	Arm Label placebo
	Target Number of Participant 40
	Arm Type Placebo comparator
	Arm Description Placebo group: 1) older than 20 years and below 75 years, 2) During the past one month in the drinking lifestyle survey, more than the average male in a week 14 unit, female in a week 7 unit, 3) abnormal serum AST(GOT) or ALT(GPT) level and below 3-fold and γ-GTP level and below 4-fold of normal range, 4) individuals agreed to participate in the study voluntarily after sufficient explanation regarding the purpose and content of study Intervention: Twice a day, 3 placebo capsules, with the water intake at the same time, for 12 weeks

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (K00-K93)Diseases of the digestive system (K70.9)Alcoholic liver disease, unspecified
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~75Year
	Description 1) older than 20 years and below 75 years 2) During the past one month in the drinking lifestyle survey, more than the average male in a week 14 unit, female in a week 7 unit 3) abnormal serum AST(GOT) or ALT(GPT) level and below 3-fold and γ-GTP level and below 4- fold of normal range 4) individuals agreed to participate in the study voluntarily after sufficient explanation regarding the purpose and content of study
Exclusion Criteria	1) alcoholism or drug addiction, heart disease, central nerve system(CNS) disorder 2) liver schirosis or hepatoma on ultrasonography 3) Alkaline Phosphatase(ALP) or lactate dehydrogenase(LDH) > 3-fold of normal range or Platelet < 105/ml or AFP > 20 ng/mL 4) viral hepatitis 5) Hepatitis B surface antigen(HBs Ag) or antibodies to hepatitis C virus(HCV Ab) positive 6) Albumin ≤ 3.5 g/dl or Total Bilirubin ≥ 3 mg/dl 7) Prothrombin time (PT) more than 15 sec or activated partial thromboplastin time (aPTT) more than 45 sec person 8) Creatinine is more than twice of the normal range 9) Thyroid Stimulating Hormone (TSH) less than 0.1 uU/ml or more than 10 uU/ml person 10) A person taking the medications for liver function(INH, valproic acid, tetracycline, allopurinol, phenytoin, phenelzine, sertraline, naproxen, diclofenac) to the start of the study within 4 weeks 11) A person taking the Cholagogues, Cholelitholytics & Hepatic Protectors, Antidotes, Detoxifying Agents & Drugs Used in Substance Dependence to the start of the study within 4 weeks 12) A person taking the asian herb, Liver function improvement and related health supplements 13) A person taking the adrenal cortex hormones or sex hormones to the start of the study within 4 weeks 14) Do not adjust the hypertensive patients(More than 160/100mmHg) 15) Does not regulate blood sugar for diabetics(FBS more than 180mg/dl or Within 3 months if you are diabetes due to starting a new drugs) 16) Within 3 months if you are diabetes due to starting a anti-phospholipid new drugs(If you are administering from 3 months old can participate) 17) Heartburn, indigestion and severe gastrointestinal symptoms of person 18) Pregnant or get the pregnant person during a clinical trial 19) planning to participate in other clinical trial during the clinical trial 20) Who was participated in the clinical trials to the start of the study within a months 21) Investigator this clinical trial the person who are deemed inappropriate
Healthy Volunteers	No

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	The change of the AST
Timepoint	6 weeks, 12 weeks
Secondary Outcome(s) 1
Outcome	The change of ALT
Timepoint	6 weeks, 12 weeks
Secondary Outcome(s) 2
Outcome	The change of γ-GTP
Timepoint	6 weeks, 12 weeks
Secondary Outcome(s) 3
Outcome	The change of AST/ALT ratio
Timepoint	6 weeks, 12 weeks
Secondary Outcome(s) 4
Outcome	The change of MFS
Timepoint	6 weeks, 12 weeks
Secondary Outcome(s) 5
Outcome	The change of total cholesterol
Timepoint	6 weeks, 12 weeks
Secondary Outcome(s) 6
Outcome	The change of triglyceride
Timepoint	6 weeks, 12 weeks
Secondary Outcome(s) 7
Outcome	The change of HDL-cholesterol
Timepoint	6 weeks, 12 weeks
Secondary Outcome(s) 8
Outcome	The change of LDL-cholesterol
Timepoint	6 weeks, 12 weeks
Secondary Outcome(s) 9
Outcome	The change of free fatty acid
Timepoint	6 weeks, 12 weeks

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

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	Not provided at time of Registration

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