The Effects of PG102, a Water Soluble Extract From Actinidia Arguta, on Serum Total IgE Levels

NCT ID: NCT01106703

Last Updated: 2010-07-27

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

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-04-30

Brief Summary

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The aim of this study was to evaluate the efficacy of PG102 at lowering levels of total IgE in asymptomatic subjects with atopy.

Detailed Description

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Conditions

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Asymptomatic Subjects With Atopy and Elevated Serum IgE

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PG102 group

Group Type EXPERIMENTAL

PG102, a water soluble extract from Actinidia arguta

Intervention Type DIETARY_SUPPLEMENT

PG102 two tables(Actinidia arguta extract:Microcrystalline cellulose(1:1)mixed powder 1120mg) twice a day for 8weeks

placebo group

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo two tables(equivalent dose of Microcrystalline cellulose) twice a day for 8weeks

Interventions

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PG102, a water soluble extract from Actinidia arguta

PG102 two tables(Actinidia arguta extract:Microcrystalline cellulose(1:1)mixed powder 1120mg) twice a day for 8weeks

Intervention Type DIETARY_SUPPLEMENT

placebo

placebo two tables(equivalent dose of Microcrystalline cellulose) twice a day for 8weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* subjects who have atopy but no allergy-related symptoms
* subjects with total IgE levels of 300IU/ml or more
* acquisition of written informed consent prior to commencement of study
* no serious clinical symptoms and normal laboratory test results; in case of abnormal finding, subjects whose conditions are not deemed severe from the judgement of investigators

Exclusion Criteria

* individuals with normal levels of total serum IgE
* ue of one or more allergic drugs
* serious clinical conditions (such as malignancies, severe cardiovascular disease etc.)
* serious mental disorder
* pregnant woman or woman of childbearing potential within 3 months
* subjects who participated in other clinical trials in the past 6months
* individuals who have a plan to participate in another clinical trials during this trial
* subjects with a history of kiwi allergy
* subjects whose conditions are inappropriate by investigators
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health & Welfare, Korea

OTHER_GOV

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Hospital

Principal Investigators

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Kyung-Up Min, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Soeul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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A060655

Identifier Type: -

Identifier Source: org_study_id

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