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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01106703
• Collaborator: Ministry of Health & Welfare, Korea (Other)
• Enrollment: 90
• Locations: 2
• Arms: 2
• Duration (Months): 16
• Patients Per Site: 45
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asymptomatic Subjects With Atopy and Elevated Serum IgE	Dietary Supplement: PG102, a water soluble extract from Actinidia arguta; Other: placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: The Effects of PG102 on Allergy-related Risk Factors: A Randomized, Double Blind, Placebo Controlled Study
• Study Start Date: Dec 1, 2006
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. serum total IgE level [8weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Soeul National University Bundang Hospital	Seongnam	Gyeonggi	Korea, Republic of
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01106703
• Other Study ID Numbers: A060655
• First Posted: Apr 20, 2010
• Last Update Posted: Jul 27, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: atopy, IgE

Study Results

No Results Posted as of Jul 27, 2010