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

The Effects of PG102 on Allergy-related Risk Factors: A Randomized, Double Blind, Placebo Controlled Study

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01106703
Enrollment
90
Registered
2010-04-20
Start date
2006-12-31
Completion date
2008-04-30
Last updated
2010-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymptomatic Subjects With Atopy and Elevated Serum IgE

Keywords

atopy, IgE

Brief summary

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

Interventions

DIETARY_SUPPLEMENTPG102, 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

OTHERplacebo

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

Sponsors

Ministry of Health & Welfare, Korea
CollaboratorOTHER_GOV
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
serum total IgE level8weeks

Secondary

MeasureTime frame
serum level of allergy-related factors, such as eosinophilic cation protein(ECP), eotaxin, thymus, and activation-regulated chemokine (TARC), IL-4, IL-5, and IL-13, skin test(atopy score), and adverse reactions8weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026