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

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

Study Overview

• Status: Completed
• Conditions: Asymptomatic Subjects With Atopy and Elevated Serum IgE
• Intervention / Treatment: Dietary supplement: PG102, a water soluble extract from Actinidia arguta; Other: placebo

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Gyeonggi
    • Seongnam, Gyeonggi, Korea, Republic of
      • Soeul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo group	Other: placebo; placebo two tables(equivalent dose of Microcrystalline cellulose) twice a day for 8weeks
Experimental: PG102 group	Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
serum total IgE level	8weeks

Secondary Outcome Measures

Outcome Measure	Time 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 reactions	8weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Ministry of Health & Welfare, Korea
• Investigators: Principal Investigator: Kyung-Up Min, M.D., Ph.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: April 19, 2010
• First Submitted That Met QC Criteria: April 19, 2010
• First Posted (Estimate): April 20, 2010

Study Record Updates

• Last Update Posted (Estimate): July 27, 2010
• Last Update Submitted That Met QC Criteria: July 23, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: atopy, IgE
• Other Study ID Numbers: A060655