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

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ClinicalTrials.gov Identifier: NCT01106703
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : July 27, 2010
Ministry of Health & Welfare, Korea
Information provided by:
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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effects of PG102 on Allergy-related Risk Factors: A Randomized, Double Blind, Placebo Controlled Study
Study Start Date : December 2006
Primary Completion Date : March 2008
Study Completion Date : April 2008

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. 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 ]

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01106703     History of Changes
Other Study ID Numbers: A060655
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: July 27, 2010
Last Verified: July 2010

Keywords provided by Seoul National University Hospital:
atopy, IgE