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

Phase 2

Completed

• Conditions: Asymptomatic Subjects With Atopy and Elevated Serum IgE
• Interventions: Dietary Supplement: PG102, a water soluble extract from Actinidia arguta; Other: placebo

• Registration Number: NCT01106703
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2008-03
• Study Completion: 2008-04
• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-23
• Last Update Posted: 2010-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PG102 group	PG102, a water soluble extract from Actinidia arguta	-
placebo group	placebo	-

Primary Outcome Measures

Name	Time	Method
serum total IgE level	8weeks

Secondary Outcome Measures

Name	Time	Method
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 reactions	8weeks

Trial Locations

Locations (2)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Soeul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of