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A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Black Bean Seed Coat Extract

NCT ID: NCT01230281

Last Updated: 2010-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2010-12-31

Brief Summary

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This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma concentration of C3G and the antioxidative markers such as total antioxidative capacity and attack of free oxygen radical will be measured.

Additional objective is to investigate the multiple dose (2 weeks) safety of daily 1000mg black bean seed coat extract.

This study, as an exploratory trial, does not required statistical hypothesis

Detailed Description

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Conditions

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Oxidative Stress

Keywords

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C3G Oxidative stress Antioxidant Black bean

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Black bean seed coat extract

Daily 1000 mg oral Black bean seed coat extract is given to each subject for 2 weeks from Day2 after measuring antioxidative marker without intervention on Day1.

Group Type EXPERIMENTAL

Black bean seed coat extract

Intervention Type OTHER

1000 mg oral daily dose for 2 weeks

Interventions

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Black bean seed coat extract

1000 mg oral daily dose for 2 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Body weight \>55 kg for male, \>45 kg for female (within 80-120% of Ideal body weight)
* Give written informed consent and voluntarily decide participation

Exclusion Criteria

* Acute or chronic disease symptom on screening
* Existing active and clinically significant disease involving more than one organ system
* Known allergy to Mulberry or other berries
* Positive drug or alcohol screening
* Smokers of 10 or more cigarettes per day
* Participation in a clinical trial during last 2 month prior to the start of the study
* Pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rural Development Administration, Korea

UNKNOWN

Sponsor Role collaborator

Seoul St. Mary's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul St. Mary's Hospital

Principal Investigators

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Dong-Seok Yim, M.D., PhD.

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

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Seoul St.Mary's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CPT2010-06

Identifier Type: -

Identifier Source: org_study_id