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The herb-drug interaction between O-Geok-San, Bojungikqitang and aspirin in ischemic stroke patients: randomized placebo controlled clinical trial

Status Approved

First Submitted Date

2016/07/25
Registered Date

2016/09/09
Last Updated Date

2016/09/02

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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	KCT0002049
Unique Protocol ID	KOMC IRB 2009-15호
Public/Brief Title	The herb-drug interaction in ischemic stroke patients
Scientific Title	The herb-drug interaction between O-Geok-San, Bojungikqitang and aspirin in ischemic stroke patients: randomized placebo controlled clinical trial
Acronym	The herb-drug interaction in ischemic stroke patients
MFDS Regulated Study	Yes
IND/IDE Protocol	Yes
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	KOMC IRB 2009-15호
Approval Date	2009-09-30
Institutional Review Board Name	Kyung Hee University Korean Medicine 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	Byung-Cheol Lee
Title
Telephone
Affiliation	Kyung Hee University Oriental Medical Center
Address	Department of Internal Medicine, College of Korean Medicine, Kyung Hee University; 1 Hoegi-dong, Dongdaemun-Ku, Seoul 130-702, Korea
Contact Person for Public Queries
Name	Byung-Cheol Lee
Title
Telephone
Affiliation	Kyung Hee University Oriental Medical Center
Address	Department of Internal Medicine, College of Korean Medicine, Kyung Hee University; 1 Hoegi-dong, Dongdaemun-Ku, Seoul 130-702, Korea
Contact Person for Updating Information
Name	Byung-Cheol Lee
Title
Telephone
Affiliation	Kyung Hee University Oriental Medical Center
Address	Department of Internal Medicine, College of Korean Medicine, Kyung Hee University; 1 Hoegi-dong, Dongdaemun-Ku, Seoul 130-702, 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	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2011-09-19 Actual
Target Number of Participant	75
Primary Completion Date	2012-01-12 , Actual
Study Completion Date	2012-01-12 , Actual
Name of Study	Kyung Hee University Oriental Medical Center
Recruitment Status	Completed
Date of First Enrollment	2011-09-19 ,

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 Health & Welfare
Organization Type	Government
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Kyung Hee University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	Herb-drug interaction can be defined as a pharmacologic or clinical response to the co-administration of a modern drug and an herbal product. There have been no randomized clinical trials focusing on herb-drug interaction. Accordingly, the aim of the present study was to assess whether Ojeoksan and Bojungikqitang interacts with an anti-platelet drug in terms of pharmacodynamics (PK) and pharmacokinetics (PD) in healthy individuals as well as in ischemic stroke patients.

Study Summary Information

Lay Summary

Herb-drug interaction can be defined as a pharmacologic or clinical response to the co-administration of a modern drug and an herbal product. There have been no randomized clinical trials focusing on herb-drug interaction. Accordingly, the aim of the present study was to assess whether Ojeoksan and Bojungikqitang interacts with an anti-platelet drug in terms of pharmacodynamics (PK) and pharmacokinetics (PD) in healthy individuals as well as in ischemic stroke patients.

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	Phase3
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Drug
Intervention Description	Eligible ischemic stroke patients were randomly allocated to either OJS treatment or placebo, in addition to aspirin. After allocation, each subject randomly received oral administration of OJS or placebo 3 times a day (1 pack volume: 14.47 g) as well as 1 capsule of Aspirin CardioTM 100 mg every morning for 2 weeks.
Number of Arms	2
Arm 1	Arm Label aspirin+herbal medicine group
	Target Number of Participant 50
	Arm Type Experimental
	Arm Description each subject randomly received oral administration of herbal medicine 3 times a day (1 pack volume: 14.47 g) as well as 1 capsule of Aspirin CardioTM 100 mg every morning for 2 weeks.
Arm 2	Arm Label aspirin+placebo group
	Target Number of Participant 25
	Arm Type Placebo comparator
	Arm Description each subject randomly received oral administration of placebo 3 times a day (1 pack volume: 14.47 g) as well as 1 capsule of Aspirin CardioTM 100 mg every morning for 2 weeks.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (I00-I99)Diseases of the circulatory system (I63.9)Cerebral infarction, unspecified
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 40Year~80Year
	Description (1) Subjects between 40 and 80 years of age (2) Subjects taking aspirin for over 3 months with a previous diagnosis of ischemic stroke
Exclusion Criteria	(1) Subjects with known allergy to aspirin (2) Subjects with aspartate transaminase (AST) or alanine transaminase (ALT) >2 × the upper limit of normal (ULN) at screening, and serum creatinine concentration >2 times the ULN at screening. (3) Heavy smoking, alcoholic subjects (4) Subjects who have a known history of GI tract surgery (5) Subjects who took Barbiturates or metabolic enzyme-related drugs within 30 days before study (6) Subjects who took any medication that can influence O-Geok-San, Bojungikqitang and aspirin whithin 10 days before study (7) Subjects who have a plan to take acupuncture treatment
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	&Pharmacokinetics/dynamics
Outcome	Platelet aggregation
Timepoint	After allocation, 0, 1week (+/- 2days) and 2 weeks (+/- 2days)
Secondary Outcome(s) 1
Outcome	plasma concentraion of acetyl salicylic acid, salicylic acid and
Timepoint	After allocation, 0, 1week (+/- 2days) and 2 weeks (+/- 2 days)
Secondary Outcome(s) 2
Outcome	plasma concentraion of thromboxane B2 level
Timepoint	After allocation, 0, 1week (+/- 2days) and 2 weeks (+/- 2 days)

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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