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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01402141
First received: July 21, 2011
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy Subjects
 Dietary Supplement: Chungkookjang
Dietary Supplement: Placebo
 Phase 2
Phase 3

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: Efficacy and Safety of Chungkookjang, a Fermented Soy Paste, on Histamine-induced Wheal Size

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • Changes in Histamine-induced Wheal Size [ Time Frame: 12weeks ] [ Designated as safety issue: Yes ]
    Histamine-induced wheal size was measured in study visit 1(0 week) and visit 3(12 week).

  • Number of Participants With Greater Than 40% Decrease in Histamine-induced Wheal Size (Wheal Size by More Than 40% Decrease in the Number of Subjects Compared With Placebo) [ Time Frame: 12weeks ] [ Designated as safety issue: Yes ]

    Number of Participants with Greater than 40% Decrease in Histamine-induced Wheal Size was measured in study visit 1(0 week) and visit 3(12 week).

    Percentage change in histamine-induced wheal size calculations were calculated by the formula ((12weeks - 0weeks) * 100/0weeks).

    Number of Participants with Greater than 40% Decrease in Histamine-induced Wheal Size compared with placebo.



Secondary Outcome Measures:
  • Changes in Immunoglobulin E [ Time Frame: 12weeks ] [ Designated as safety issue: Yes ]
    Immunoglobulin E was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in Serum Histamine [ Time Frame: 12weeks ] [ Designated as safety issue: Yes ]
    Serum histamine was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in Interferon-gamma [ Time Frame: 12weeks ] [ Designated as safety issue: Yes ]
    Interferon-gamma was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in Interleukin-4 [ Time Frame: 12weeks ] [ Designated as safety issue: Yes ]
    Interleukin-4 was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in Eosinophil [ Time Frame: 12weeks ] [ Designated as safety issue: Yes ]
    Eosinophil was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in Eosinophil Cationic Protein(ECP) [ Time Frame: 12weeks ] [ Designated as safety issue: Yes ]
    Eosinophil Cationic Protein(ECP) was measured in study visit 1(0 week) and visit 3(12 week).


Enrollment: 60
Study Start Date: October 2010
Study Completion Date: September 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chungkookjang Dietary Supplement: Chungkookjang
Chungkookjang(35g/say)for 12 weeks
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo(35g/day) for 12 weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402141

Locations
Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Sponsors and Collaborators
Chonbuk National University Hospital
Investigators
Principal Investigator: Baek-Hwan Cho, MD., PhD Chonbuk National University Hospital
  More Information

No publications provided by Chonbuk National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Soo-Wan Chae, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01402141     History of Changes
Other Study ID Numbers: SunChang-TCKJ-001
Study First Received: July 21, 2011
Results First Received: July 11, 2012
Last Updated: November 21, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Chonbuk National University Hospital:
Chungkookjang
histamine
skin reaction
wheal

Additional relevant MeSH terms:
Histamine
Histamine phosphate
Histamine Agonists
Histamine Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013