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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Effects of PG102 on Allergy-related Risk Factors: A Randomized, Double Blind, Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • serum total IgE level [ Time Frame: 8weeks ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106703

Locations
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
Investigators
Principal Investigator: Kyung-Up Min, M.D., Ph.D. Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01106703     History of Changes
Other Study ID Numbers: A060655
Study First Received: April 19, 2010
Last Updated: July 23, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
atopy, IgE

ClinicalTrials.gov processed this record on September 18, 2014