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Effectiveness and safety of Korean red ginseng extracts (KGC05P0) on improving blood glucose in adults with prediabetes: A randomized, double-blind, placebo-controlled trial

Status Approved

First Submitted Date

2019/12/23
Registered Date

2020/01/22
Last Updated Date

2020/02/19

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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	KCT0004639
Unique Protocol ID	RIMN_Red_gin
Public/Brief Title	Korean red ginseng extracts for improvement of blood glucose with prediabetes
Scientific Title	Effectiveness and safety of Korean red ginseng extracts (KGC05P0) on improving blood glucose in adults with prediabetes: A randomized, double-blind, placebo-controlled 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	KOMCIRB-180122-HR-004
Approval Date	2018-04-20
Institutional Review Board Name	Institutional Review Board of Kyung Hee University Korean Medicine Hospital
Institutional Review Board Address	23, Kyungheedae-ro, Dongdaemun-gu, Seoul
Institutional Review Board Telephone	02-958-9105
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	Euiju Lee
Title	Prof
Telephone	+82-2-958-9730
Affiliation	Kyung Hee University Oriental Medical Center
Address	23 Kyungheedaero, Dongdaemungu, Seoul
Contact Person for Public Queries
Name	Euiju Lee
Title	Prof
Telephone	+82-2-958-9730
Affiliation	Kyung Hee University Oriental Medical Center
Address	23 Kyungheedaero, Dongdaemungu, Seoul
Contact Person for Updating Information
Name	Euiju Lee
Title	Prof
Telephone	+82-2-958-9730
Affiliation	Kyung Hee University Oriental Medical Center
Address	23 Kyungheedaero, Dongdaemungu, Seoul

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	2018-04-20 Actual
Target Number of Participant	120
Primary Completion Date	2019-06-10 , Actual
Study Completion Date	2019-11-08 , Actual
Name of Study	Kyung Hee University Oriental Medicine Hospital at Gangdong
Recruitment Status	Completed
Date of First Enrollment	2018-04-20 ,

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	Korea Ginseng Corporation
Organization Type	Others
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Korea Ginseng Corporation
Organization Type	Others

7. Study Summary

Study Summary Information
Lay Summary	Prediabetes is characterized by an impaired fasting glucose and/or impaired glucose tolerance status, which often remains undetected or asymptomatic but easily can elevate future risks of developing type 2 diabetes mellitus. It is known that 314 million people (8.2% of the adult population) had prediabetes in 2013; however, the number is supposed to reach 472 million (9.0% of the adult population) by 2025, and it is also reported that approximately 40–50% of prediabetic people develop type 2 diabetes mellitus within 10 years. Red ginseng is obtained after ginseng is steamed and dried, which is widely used for functional foods. Saponin, a main ingredient, is known to have immune regulatory function, anticancer effects, antioxidant effects, and regulatory effect for metabolic syndrome, while non-saponin fractions of ginseng is reported to be effective for decreasing blood glucose and regulating postprandial hyperglycemia. This clinical research is to evaluate the effectiveness and safety of red ginseng extract (KGC05P0) for adults with prediabetes to regulate fasting blood glucose, postprandial glucose, and other relevant index.

Study Summary Information

Lay Summary

Prediabetes is characterized by an impaired fasting glucose and/or impaired glucose tolerance status, which often remains undetected or asymptomatic but easily can elevate future risks of developing type 2 diabetes mellitus. It is known that 314 million people (8.2&#37; of the adult population) had prediabetes in 2013; however, the number is supposed to reach 472 million (9.0&#37; of the adult population) by 2025, and it is also reported that approximately 40–50&#37; of prediabetic people develop type 2 diabetes mellitus within 10 years.
Red ginseng is obtained after ginseng is steamed and dried, which is widely used for functional foods. Saponin, a main ingredient, is known to have immune regulatory function, anticancer effects, antioxidant effects, and regulatory effect for metabolic syndrome, while non-saponin fractions of ginseng is reported to be effective for decreasing blood glucose and regulating postprandial hyperglycemia. 
This clinical research is to evaluate the effectiveness and safety of red ginseng extract (KGC05P0) for adults with prediabetes to regulate fasting blood glucose, postprandial glucose, and other relevant index.

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	Red ginseng (KGC05P0) or Placebo Tablets, 400mg/tablet, 2 Tablets/time, Twice a day, Oral administration for 12 weeks
Number of Arms	2
Arm 1	Arm Label Red ginseng group
	Target Number of Participant 60
	Arm Type Experimental
	Arm Description Red ginseng (KGC05P0) Tablets, 400mg/tablet, 2 Tablets/time, Twice a day, Oral administration for 12 weeks
Arm 2	Arm Label Placebo group
	Target Number of Participant 60
	Arm Type Placebo comparator
	Arm Description Placebo Tablets, 400mg/tablet, 2 Tablets/time, Twice a day, Oral administration for 12 weeks

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (E00-E90)Endocrine, nutritional and metabolic diseases (E14.9)Unspecified diabetes mellitus, without complications Prediabetic State
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~64Year
	Description 1) Male or female adults aged 19 to 64 2) Participant who satisfies one of the followings; a. fasting blood glucose level between 100 and 125 mg/dL b. blood glucose level between 140 and 199 mg/dL with oral glucose tolerance test c. HbA1C level between 5.7 and 6.4% 3) Participants who voluntarily assent to participate in the study and sign the informed consents
Exclusion Criteria	1) Participants taking hypoglycemic agents within 3 months 2) Patients diagnosed with thyroid diseases and under their treatments 3) Patients diagnosed with chronic gastrointestinal disorders 4) Uncontrolled hypertensive patients 5) Patients taking continuous treatments due to significantly glycometabolism-related disorders 6) Participants with 30kg/m2 or more of body mass index 7) Participants with renal dysfunction (1.5 times or more of upper limit of normal creatinine level), hepatic dysfunction (2.5 times or more of upper limits of normal alanine and aspartate aminotransferase levels), malignant tumors, or mental diseases 8) Participants who took any medications, herb medicines, or functional supplements for 3 days or more within 4 weeks 9) Pregnant or lactating females 10) Participants who took any surgeries due to significantly glycometabolism-related disorders within recent 6 months 11) Participants who have ever addicted to any drugs or alcohol 12) Participants who participated in other clinical studies within 1 month 13) Participants who are allergic or overreactive to the investigator’s product 14) Participants who are illiterate or cannot read written letters 15) Participants who have any other inappropriate reasons to participant in the study, judged by the investigators
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	Oral Glucose Tolerance Test
Timepoint	Screenging visit(within 2 weeks from random allocation), Week 12
Primary Outcome(s) 2
Outcome	Fasting glucose
Timepoint	Screenging visit(within 2 weeks from random allocation), Week 12
Secondary Outcome(s) 1
Outcome	blood insulin
Timepoint	Week 0, Week 12
Secondary Outcome(s) 2
Outcome	HbA1c
Timepoint	Screenging visit(within 2 weeks from random allocation), Week 12
Secondary Outcome(s) 3
Outcome	C-peptide
Timepoint	Week 0, Week 6, Week 12
Secondary Outcome(s) 4
Outcome	Lipid profiles (triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, free fatty acid)
Timepoint	Week 0, Week 12
Secondary Outcome(s) 5
Outcome	Abdominal obesity index (waist circumference, waist hip ratio)
Timepoint	Week 0, Week 12
Secondary Outcome(s) 6
Outcome	HOMA-IR
Timepoint	Week 0, Week 12
Secondary Outcome(s) 7
Outcome	Vital sign (systolic blood pressure, diastolic blood pressure, pulse rate)
Timepoint	Screenging visit(within 2 weeks from random allocation), Week 6, Week 12
Secondary Outcome(s) 8
Outcome	Labarotary test
Timepoint	Screenging visit(within 2 weeks from random allocation), Week 12
Secondary Outcome(s) 9
Outcome	Adverse events
Timepoint	Week 6, 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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