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A Human Trial to Evaluate the Effects of Chungkookjang on Histamine-induced Wheal Size in Healthy Subjects

NCT ID: NCT01402141

Last Updated: 2012-11-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-09-30

Brief Summary

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The investigators investigate the effect of Chungkookjang on histamine-induced skin reaction in a double-blind, randomized, placebo-controlled, human trial

Detailed Description

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Sixty volunteers (aged 20-80) who gave a written consent before entering the study, were randomized in two groups of thirty subjects each. The skin prick test with histamine was performed on the ventral forearm, 10 cm from the elbow, before and after supplement administration, as well as three times daily for 12 weeks of chungkookjang(35g/day) or placebo(35g/day)intake.

Conditions

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Healthy Subjects

Keywords

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Chungkookjang histamine skin reaction wheal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Chungkookjang

Group Type EXPERIMENTAL

Chungkookjang

Intervention Type DIETARY_SUPPLEMENT

Chungkookjang(35g/say)for 12 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo(35g/day) for 12 weeks

Interventions

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Chungkookjang

Chungkookjang(35g/say)for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo(35g/day) for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Histamine skin prick test: above 3mm

Exclusion Criteria

* No medication or cosmetic creams were allowed during Substances the previous week and no drugs containing corticosteroids or ACTH within 3 months.
* Patients on systemic or topical treatment with immunosuppressive agents on the nondominant arm were excluded
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo-Wan Chae

Clinical Trial Center for Functional Foods

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Baek-Hwan Cho, MD., PhD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Locations

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Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status

Countries

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South Korea

References

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Kwon DY, Yang HJ, Kim MJ, Kang HJ, Kim HJ, Ha KC, Back HI, Kim SY, Park EO, Kim MG, Yun SK, Chae SW, Cho BH. Influence of the Chungkookjang on histamine-induced wheal and flare skin response: a randomized, double-blind, placebo controlled trial. BMC Complement Altern Med. 2011 Dec 5;11:125. doi: 10.1186/1472-6882-11-125.

Reference Type DERIVED
PMID: 22136279 (View on PubMed)

Other Identifiers

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SunChang-TCKJ-001

Identifier Type: -

Identifier Source: org_study_id