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

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ClinicalTrials.gov Identifier: NCT01402141
Recruitment Status : Completed
First Posted : July 26, 2011
Results First Posted : November 12, 2012
Last Update Posted : November 22, 2012
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Healthy Subjects Dietary Supplement: Chungkookjang Dietary Supplement: Placebo Phase 2 Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Chungkookjang, a Fermented Soy Paste, on Histamine-induced Wheal Size
Study Start Date : October 2010
Primary Completion Date : July 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Chungkookjang Dietary Supplement: Chungkookjang
Chungkookjang(35g/say)for 12 weeks
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo(35g/day) for 12 weeks


Outcome Measures

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

  2. 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 ]

    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 :
  1. Changes in Immunoglobulin E [ Time Frame: 12weeks ]
    Immunoglobulin E was measured in study visit 1(0 week) and visit 3(12 week).

  2. Changes in Serum Histamine [ Time Frame: 12weeks ]
    Serum histamine was measured in study visit 1(0 week) and visit 3(12 week).

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

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

  5. Changes in Eosinophil [ Time Frame: 12weeks ]
    Eosinophil was measured in study visit 1(0 week) and visit 3(12 week).

  6. Changes in Eosinophil Cationic Protein(ECP) [ Time Frame: 12weeks ]
    Eosinophil Cationic Protein(ECP) was measured in study visit 1(0 week) and visit 3(12 week).


Eligibility Criteria

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: July 26, 2011    Key Record Dates
Results First Posted: November 12, 2012
Last Update Posted: November 22, 2012
Last Verified: November 2012

Keywords provided by Soo-Wan Chae, 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
Physiological Effects of Drugs