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

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Asymptomatic Subjects With Atopy and Elevated Serum IgE

Treatments: Dietary Supplement: PG102, a water soluble extract from Actinidia arguta; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01106703

A060655

Details and patient eligibility

About

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

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

PG102 group

Experimental group

Treatment:

Dietary Supplement: PG102, a water soluble extract from Actinidia arguta

placebo group

Placebo Comparator group

Treatment:

Other: placebo