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

July 21, 2011
November 21, 2012
October 2010
July 2011   (final data collection date for primary outcome measure)
  • 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.

Histamine-induced wheal size [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01402141 on ClinicalTrials.gov Archive Site
  • 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).
  • Immunoglobulin E [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • serum histamine [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Interferon-gamma [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Interleukin-4 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Eosinophil [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Eosinophil Cationic Protein [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Human Trial to Evaluate the Effects of Chungkookjang on Histamine-induced Wheal Size in Healthy Subjects
Efficacy and Safety of Chungkookjang, a Fermented Soy Paste, on Histamine-induced Wheal Size

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

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Healthy Subjects
  • Dietary Supplement: Chungkookjang
    Chungkookjang(35g/say)for 12 weeks
  • Dietary Supplement: Placebo
    Placebo(35g/day) for 12 weeks
  • Experimental: Chungkookjang
    Intervention: Dietary Supplement: Chungkookjang
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01402141
SunChang-TCKJ-001
Yes
Soo-Wan Chae, Chonbuk National University Hospital
Chonbuk National University Hospital
Not Provided
Principal Investigator: Baek-Hwan Cho, MD., PhD Chonbuk National University Hospital
Chonbuk National University Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP