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  • Status : Approved
    • First Submitted Date : 2018/12/07
    • Registered Date : 2019/02/12
    • Last Updated Date : 2019/01/22
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1. Background

Background Information
CRIS
Registration Number
KCT0003497 
Unique Protocol ID BBRI_ROE2 
Public/Brief Title Efficacy and safety of Rubus occidentalis extract on serum cholesterol 
Scientific Title Efficacy and safety of Rubus occidentalis extract on serum cholesterol; A 12 week, randomized, double-blind, placebo-controlled clinical trial  
Acronym  
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 CUH 2018-03-044-001 
Approval Date 2018-05-08 
Institutional Review Board  
Name Chonbuk National University Hospital Institutional Review Board 
Address 20, Geonji-ro, Deokjin-gu, Jeonju-si, Jeollabuk-do 
Telephone 063-250-2154 
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Soowan Chae 
Title MD., Ph.D. 
Telephone +82-63-270-3089 
Affiliation Chonbuk National University Hospital 
Address 20 Geonji-ro, Deokjin-gu, Jeonju-si 
Contact Person for Public Queries
Name Soo-Hyun Park 
Title Researcher 
Telephone +82-63-259-3048 
Affiliation Chonbuk National University Hospital 
Address 20 Geonji-ro, Deokjin-gu, Jeonju-si 
Contact Person for Updating Information
Name Soo-Hyun Park 
Title Researcher 
Telephone +82-63-259-3048 
Affiliation Chonbuk National University Hospital 
Address 20 Geonji-ro, Deokjin-gu, Jeonju-si 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Recruiting  
Date of First Enrollment 2018-06-25 , Actual
Target Number of Participant 100
Primary Completion Date 2019-02-08 , Anticipated
Study Completion Date 2019-03-08 , Anticipated
Recruitment Status by Participating Study Site 1
Name of Study Site Chonbuk National University Hospital 
Recruitment Status Recruiting  
Date of First Enrollment 2018-06-25 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Berry&Bio Food Research Institue 
Organization Type Others  
Project ID  

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Berry&Bio Food Research Institue 
Organization Type Others  

7. Study Summary

Study Summary Information
Lay Summary This study is a 12-week, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of Rubus occidentalis extract for cholesterol-lowering effect.
Hypercholesterolemic participants who had not been diagnosed with any disease and met the inclusion criteria are recruited for this study. The 100 subjects are randomly assigned to Rubus occidentalis extract and placebo groups. Outcomes include measurement of efficacy and safety.  

8. Study Design

Study Design Information
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 Test supplement: Rubus occidentalis extract (750 mg/day)
Placebo supplement: Placebo
12-week, 4 tab/day, twice a day  
Number of Arms
Arm 1 Arm Label Test group 
Target Number of Participant 50 
Arm Type Active comparator 
Arm Description Rubus occidentalis extract (750 mg/day) 12-week, 4 tab/day, twice a day 
Arm 2 Arm Label Placebo group 
Target Number of Participant 50 
Arm Type Placebo comparator 
Arm Description Placebo 12-week, 4 tab/day, twice a day 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Endocrine, nutritional and metabolic disease
Hypercholesterolemia  
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 20 Year ~ 75 Year
Description 200 mg/dl ≤ cholesterol ≤ 249 mg/dl
or 130 ≤ LDL-cholesterol ≤ 170 mg/dl  
Exclusion Criteria 1) treatment with hypolipidemic drugs within the past 3 months
2) those who receive treatment, rehabilitation, or inpatient treatment for heart disease or central nervous system disease
3) Creatinine level more than 2 times the upper limit of the normal range
4) ALT or AST level more than 3 times the upper limit of the normal range
5) uncontrolled diabetes, hypertension, or thyroid disease  
Healthy Volunteers  

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
Outcome Total cholesterol 
Timepoint 0 week, 6 week, 12 week 
Primary Outcome(s) 2 
Outcome LDL-cholesterol 
Timepoint 0 week, 6 week, 12 week 
Primary Outcome(s) 3 
Outcome HDL-cholesterol 
Timepoint 0 week, 6 week, 12 week 
Secondary Outcome(s) 1 
Outcome Triglyceride 
Timepoint 0 week, 6 week, 12 week 
Secondary Outcome(s) 2 
Outcome Apolipoprotein AⅠ 
Timepoint 0 week, 12 week 
Secondary Outcome(s) 3 
Outcome Apolipoprotein B 
Timepoint 0 week, 12 week 

11. Study Results and Publication

Study Results and Publication Information
Result Registerd No

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

Sharing of Study Data Information
Sharing Statement Undecided 
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