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
1 other identifier
interventional
90
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2006
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 19, 2010
CompletedFirst Posted
Study publicly available on registry
April 20, 2010
CompletedJuly 27, 2010
July 1, 2010
1.2 years
April 19, 2010
July 23, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
serum total IgE level
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
8weeks
Study Arms (2)
PG102 group
EXPERIMENTALplacebo group
PLACEBO COMPARATORInterventions
PG102 two tables(Actinidia arguta extract:Microcrystalline cellulose(1:1)mixed powder 1120mg) twice a day for 8weeks
placebo two tables(equivalent dose of Microcrystalline cellulose) twice a day for 8weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Soeul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Kyung-Up Min, M.D., Ph.D.
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 19, 2010
First Posted
April 20, 2010
Study Start
December 1, 2006
Primary Completion
March 1, 2008
Study Completion
April 1, 2008
Last Updated
July 27, 2010
Record last verified: 2010-07