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Completed

NCT Number: NCT01106703

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

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

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Key information

Conditions

Asymptomatic Subjects With Atopy and Elevated Serum IgE Epilepsy, Idiopathic Generalized

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Soeul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PG102, a water soluble extract from Actinidia arguta

Dietary Supplement

PG102 two tables(Actinidia arguta extract:Microcrystalline cellulose(1:1)mixed powder 1120mg) twice a day for 8weeks

Placebo

Other

placebo two tables(equivalent dose of Microcrystalline cellulose) twice a day for 8weeks

Primary outcomes

  1. serum total IgE level

    Time frame: 8weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Ministry of Health & Welfare, Korea

Registry information

Official study title

The Effects of PG102 on Allergy-related Risk Factors: A Randomized, Double Blind, Placebo Controlled Study

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 20, 2010
Registry last updated
Jul 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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