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Influence of SW-02 (Ginseng-Rehmanniae complex) in healthy subjects on their hematologic and immunologic responses :a Pilot study.

Status Approved

First Submitted Date

2017/08/30
Registered Date

2018/01/09
Last Updated Date

2017/11/30

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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	KCT0002652
Unique Protocol ID	IS14TISF0016
Public/Brief Title	Influence of kyungokgo in healthy subjects on their hematologic and immunologic responses : a pilot study
Scientific Title	Influence of SW-02 (Ginseng-Rehmanniae complex) in healthy subjects on their hematologic and immunologic responses :a Pilot study.
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
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	IS14TISF0016
Approval Date	2015-04-08
Institutional Review Board Name	CATHOLIC KWANDONG UNIVERSITY INTERNATIONAL ST.MARY’S HOSPITAL INSTITUTIONAL REVIEW BOARD.
Institutional Review Board Address
Institutional Review Board Telephone
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	hyejung kim
Title	prof
Telephone	+82-32-290-3318
Affiliation	Catholic Kwandong University
Address	Kangwon do gangleungsi bumilro 579-24
Contact Person for Public Queries
Name	narae yang
Title	assis-prof
Telephone	+82-32-290-3318
Affiliation	Catholic Kwandong University International St.Mary's Hospital
Address	Incheon seogu simgokro 100-25 Catholic Kwandong University International St.Mary's Hospital
Contact Person for Updating Information
Name	narae yang
Title	assis-prof
Telephone	+82-32-290-3318
Affiliation	Catholic Kwandong University International St.Mary's Hospital
Address	Incheon seogu simgokro 100-25 Catholic Kwandong University International St.Mary's Hospital

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	2015-05-01 Actual
Target Number of Participant	30
Primary Completion Date	2015-05-22 , Actual
Study Completion Date	2015-05-22 , Actual
Name of Study	Catholic Kwandong University International St.Mary's Hospital
Recruitment Status	Completed
Date of First Enrollment	2015-05-01 ,

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	Catholic Kwandong University
Organization Type	University
Project ID	201406880001

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Catholic Kwandong University International St.Mary's Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	This randomized, double-blind, placebo-controlled, single-center pilot study was undertaken to investigate the safety and efficacy of Gyeongokgo (GOK) with hematologic and serologic testing and to investigate the change of the quality of life in healthy individuals. The study population comprised 29 healthy volunteer subjects between the ages of 21 and 60 years who were randomly placed into the GOK group (n = 20) or placebo control group (n = 9) and instructed to take one treatment packet twice daily for 4 weeks. Subjects were assessed using the Fatigue Severity Scale (FSS) and Short Form 36 Health Survey (SF-36) and underwent hematologic and serologic tests and body composition analysis before and after the study period.

Study Summary Information

Lay Summary

 This randomized, double-blind, placebo-controlled, single-center pilot study was undertaken to investigate the safety and efficacy of Gyeongokgo (GOK) with hematologic and serologic testing and to investigate the change of the quality of life  in healthy individuals. The study population comprised 29 healthy volunteer subjects between the ages of 21 and 60 years who were randomly placed into the GOK group (n = 20) or placebo control group (n = 9) and instructed to take one treatment packet twice daily for 4 weeks. Subjects were assessed using the Fatigue Severity Scale (FSS) and Short Form 36 Health Survey (SF-36) and underwent hematologic and serologic tests and body composition analysis before and after the study period.

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	Phase4
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Drug
Intervention Description	GOK and placebo preparation sealed 120-mL packet of liquid GOK (GOK group) or liquid placebo (control group) twice a day after breakfast and dinner, for 4 weeks.
Number of Arms	2
Arm 1	Arm Label GOK group
	Target Number of Participant 20
	Arm Type Experimental
	Arm Description GOK sealed 120-mL packet of liquid GOK (GOK group) or liquid placebo (control group) twice a day after breakfast and dinner, for 4 weeks
Arm 2	Arm Label placebo group
	Target Number of Participant 10
	Arm Type Placebo comparator
	Arm Description GOK sealed 120-mL packet of liquid GOK (GOK group) or liquid placebo (control group) twice a day after breakfast and dinner, for 4 weeks

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	Not Applicable-Etc
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~40Year
	Description . Subjects were physically and mentally healthy males and females aged 21 to 60 who had seen one of the clinical trial flyers posted in the hospital between March and April 2015 and had willfully consented to participate
Exclusion Criteria	1) underlying diseases including hypertension, hepatitis, or tuberculosis; 2) a history of endocrin ologic or hormone disorders; 3) a history of hepato-pancreato-biliary or renal disorders; 4) a history of impaired blood glucose regulation (i.e., impaired fasting glucose, impaired glucose tolerance, or diabetes); 5) steroid or hormonal drug use less than 1 month before the start of the study; 6) pregnancy or breastfeeding; and 7) any abnormal findings that might possibly have impacted the study results. The researchers first confirmed any matters that contravened the clinical trial conditions via a phone call or visit to each subject.
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	/Safety/Efficacy
Outcome	fatigue severity scale short form health survey-36
Timepoint	after 4weeks
Secondary Outcome(s) 1
Outcome	hematologic and serological
Timepoint	after 4weeks

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	Yes
Time of Sharing	2023. 1
Way of Sharing	Available on Request (synthe2@naver.com)

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