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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01402141
Recruitment Status : Completed
First Posted : July 26, 2011
Results First Posted : November 12, 2012
Last Update Posted : November 22, 2012
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Healthy Subjects
Interventions: Dietary Supplement: Chungkookjang
Dietary Supplement: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The criteria were an age from 19 to 80 years, Histamine skin prick test: above 3mm

Reporting Groups

Chungkookjang(3times/day, 3packs/day, 35g/day) for 12weeks

Chungkookjang: The Chungkookjang was manufactured from raw beans, peels made after freeze-drying


Placebo(3times/day, 3packs/day, 35g/day) for 12weeks

Placebo : Amount and calorie of placebo are same with Chungkookjang.

Participant Flow:   Overall Study
    Chungkookjang   Placebo
STARTED   30   30 
COMPLETED   29   28 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Chungkookjang(35g) No text entered.
Placebo(35g) No text entered.
Total Total of all reporting groups

Baseline Measures
   Chungkookjang(35g)   Placebo(35g)   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   30   30   60 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 35.5  (11.9)   34.2  (12.9)   34.9  (12.3) 
[Units: Participants]
Female   20   28   48 
Male   10   2   12 
Region of Enrollment 
[Units: Participants]
Korea, Republic of   30   30   60 

  Outcome Measures

1.  Primary:   Changes in Histamine-induced Wheal Size   [ Time Frame: 12weeks ]

2.  Primary:   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 ]

3.  Secondary:   Changes in Immunoglobulin E   [ Time Frame: 12weeks ]

4.  Secondary:   Changes in Serum Histamine   [ Time Frame: 12weeks ]

5.  Secondary:   Changes in Interferon-gamma   [ Time Frame: 12weeks ]

6.  Secondary:   Changes in Interleukin-4   [ Time Frame: 12weeks ]

7.  Secondary:   Changes in Eosinophil   [ Time Frame: 12weeks ]

8.  Secondary:   Changes in Eosinophil Cationic Protein(ECP)   [ Time Frame: 12weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Baek-Hwan Cho, MD
Organization: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
phone: 82-63-250-1579

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Soo-Wan Chae, Chonbuk National University Hospital Identifier: NCT01402141     History of Changes
Other Study ID Numbers: SunChang-TCKJ-001
First Submitted: July 21, 2011
First Posted: July 26, 2011
Results First Submitted: July 11, 2012
Results First Posted: November 12, 2012
Last Update Posted: November 22, 2012