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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.
Sponsor:
Collaborator:
Ministry of Health & Welfare, Korea
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01106703
First received: April 19, 2010
Last updated: July 23, 2010
Last verified: July 2010

April 19, 2010
July 23, 2010
December 2006
March 2008   (final data collection date for primary outcome measure)
serum total IgE level [ Time Frame: 8weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01106703 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Asymptomatic Subjects With Atopy and Elevated Serum IgE
  • 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
  • Other: placebo
    placebo two tables(equivalent dose of Microcrystalline cellulose) twice a day for 8weeks
  • Experimental: PG102 group
    Intervention: Dietary Supplement: PG102, a water soluble extract from Actinidia arguta
  • Placebo Comparator: placebo group
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
April 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01106703
A060655
Yes
Seoul National University Hospital
Seoul National University Hospital
Ministry of Health & Welfare, Korea
Principal Investigator: Kyung-Up Min, M.D., Ph.D. Seoul National University Hospital
Seoul National University Hospital
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP