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
Results First Received: July 11, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Healthy Subjects
Interventions: Dietary Supplement: Chungkookjang
Dietary Supplement: Placebo

  Participant Flow
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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
  Description
Chungkookjang

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

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

Placebo

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  
NOT COMPLETED     1     2  



  Baseline Characteristics
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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
  Description
Chungkookjang(35g) No text entered.
Placebo(35g) No text entered.
Total Total of all reporting groups

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



  Outcome Measures
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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
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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
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  More Information
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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
e-mail: chobh@jbnu.ac.kr


No publications provided by Chonbuk National University Hospital

Publications automatically indexed to this study:

Responsible Party: Soo-Wan Chae, 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