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A 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Aronia and Red Ginseng mixture on improvement of Hyperglycemia

Status Approved

First Submitted Date

2021/01/20
Registered Date

2021/01/27
Last Updated Date

2021/02/02

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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	KCT0005830
Unique Protocol ID	YD-HG-AGM
Public/Brief Title	A 12 weeks, randomized, double-blind, placebo-controlled human trial of Aronia and Red Ginseng mixture on improvement of Hyperglycemia
Scientific Title	A 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Aronia and Red Ginseng mixture on improvement of Hyperglycemia
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	WSOH IRB H1909-02
Approval Date	2019-09-23
Institutional Review Board Name	Institutional Review Board of the Woosuk University Korean Medicine Hospital
Institutional Review Board Address	46, Eoeun-ro, Wansan-gu, Jeonju-si, Jeollabuk-do
Institutional Review Board Telephone	063-220-8750
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	Soo jung Park
Title	KM Doctor
Telephone	+82-63-220-8676
Affiliation	Woosuk University Korean Medicine Medical Center
Address	46, Eoeun-ro, Wansan-gu, Jeonju-si, Jeollabuk-do
Contact Person for Public Queries
Name	Soo jung Park
Title	KM Doctor
Telephone	+82-63-220-8676
Affiliation	Woosuk University Korean Medicine Medical Center
Address	46, Eoeun-ro, Wansan-gu, Jeonju-si, Jeollabuk-do
Contact Person for Updating Information
Name	Soo jung Park
Title	KM Doctor
Telephone	+82-63-220-8676
Affiliation	Woosuk University Korean Medicine Medical Center
Address	46, Eoeun-ro, Wansan-gu, Jeonju-si, Jeollabuk-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	Completed
Date of First Enrollment	2019-12-16 Actual
Target Number of Participant	80
Primary Completion Date	2020-05-28 , Actual
Study Completion Date	2020-07-16 , Actual
Name of Study	Woosuk University Korean Medicine Medical Center
Recruitment Status	Completed
Date of First Enrollment	2019-12-16 ,

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
2. Source of Monetary/Material Support
Organization Name	YD Nutraceuticals
Organization Type	Others
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Woosuk University Korean Medicine Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	This study is 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Aronia and Red Ginseng mixture on improvement of Hyperglycemia. For adults with Hyperglycemia, prescribed Aronia and Red Ginseng mixture for 12 weeks. The measures of this study are to evaluate the efficacy and safety of Aronia and Red Ginseng mixture versus placebo for improvement of Hyperglycemia.

Study Summary Information

Lay Summary

This study is 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Aronia and Red Ginseng mixture on improvement of Hyperglycemia. For adults with Hyperglycemia, prescribed Aronia and Red Ginseng mixture for 12 weeks. The measures of this study are to evaluate the efficacy and safety of Aronia and Red Ginseng mixture versus placebo for improvement of Hyperglycemia.

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	• Aronia and Red Ginseng mixture group: Twice a day, 1 tablet once, after breakfast and dinner, for 12 weeks(8 g/day, 8 g/day for Aronia and Red Ginseng mixture) • Placebo group: Twice a day, 1 tablet once, after breakfast and dinner, for 12 weeks(8 g/day)
Number of Arms	2
Arm 1	Arm Label Aronia and Red Ginseng mixture group
	Target Number of Participant 40
	Arm Type Experimental
	Arm Description • Aronia and Red Ginseng mixture group: Twice a day, 1 tablet once, after breakfast and dinner, for 12 weeks(8 g/day, 8 g/day for Aronia and Red Ginseng mixture)
Arm 2	Arm Label Placebo group
	Target Number of Participant 40
	Arm Type Placebo comparator
	Arm Description • Placebo group: Twice a day, 1 tablet once, after breakfast and dinner, for 12 weeks(8 g/day)

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~70Year
	Description 1) Males and females aged over 19 years and under 70 years at the screening examination 2) Fasting blood glucose≥100 mg/dL and <140 mg/dL 3) Participants who have fully understand the information provided about the study voluntarily decided to participate and agree to comply with precautions
Exclusion Criteria	1) Patients who need care of diabetes at the screening examination. 2) Patients who take medicine for glucose and intake health functional food within 3 months prior to the screening examination. 3) Patients with a history of medicine or alcohol abuse 4) Patients who have participated in other clinical trials within 3 months prior to the screening examination
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	Efficacy
Outcome	fasting glucose
Timepoint	screening, 0, 12 week
Primary Outcome(s) 2
Outcome	postprandial glucose
Timepoint	screening, 0, 12 week
Secondary Outcome(s) 1
Outcome	Insulin
Timepoint	0, 12 week
Secondary Outcome(s) 2
Outcome	HbA1c(Hemoglobin A1c)
Timepoint	screening, 12 week
Secondary Outcome(s) 3
Outcome	lipid profile
Timepoint	screening, 0, 12 week
Secondary Outcome(s) 4
Outcome	C-peptide
Timepoint	0, 12 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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