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

This study has been completed.
Ministry of Health & Welfare, Korea
Information provided by:
Seoul National University Hospital Identifier:
First received: April 19, 2010
Last updated: July 23, 2010
Last verified: July 2010
The aim of this study was to evaluate the efficacy of PG102 at lowering levels of total IgE in asymptomatic subjects with atopy.

Condition Intervention Phase
Asymptomatic Subjects With Atopy and Elevated Serum IgE
Dietary Supplement: PG102, a water soluble extract from Actinidia arguta
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effects of PG102 on Allergy-related Risk Factors: A Randomized, Double Blind, Placebo Controlled Study

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • serum total IgE level [ Time Frame: 8weeks ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 8weeks ]

Enrollment: 90
Study Start Date: December 2006
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: placebo group Other: placebo
placebo two tables(equivalent dose of Microcrystalline cellulose) twice a day for 8weeks


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01106703

Korea, Republic of
Soeul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Ministry of Health & Welfare, Korea
Principal Investigator: Kyung-Up Min, M.D., Ph.D. Seoul National University Hospital
  More Information

Responsible Party: Seoul National University Hospital Identifier: NCT01106703     History of Changes
Other Study ID Numbers: A060655
Study First Received: April 19, 2010
Last Updated: July 23, 2010

Keywords provided by Seoul National University Hospital:
atopy, IgE processed this record on May 25, 2017