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

November 21, 2012 updated by: Soo-Wan Chae, Chonbuk National University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
        • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Placebo(35g/day) for 12 weeks
Experimental: Chungkookjang
Dietary supplement: Chungkookjang
Chungkookjang(35g/say)for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12weeks
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.
12weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Immunoglobulin E
Time Frame: 12weeks
Immunoglobulin E was measured in study visit 1(0 week) and visit 3(12 week).
12weeks
Changes in Serum Histamine
Time Frame: 12weeks
Serum histamine was measured in study visit 1(0 week) and visit 3(12 week).
12weeks
Changes in Interferon-gamma
Time Frame: 12weeks
Interferon-gamma was measured in study visit 1(0 week) and visit 3(12 week).
12weeks
Changes in Interleukin-4
Time Frame: 12weeks
Interleukin-4 was measured in study visit 1(0 week) and visit 3(12 week).
12weeks
Changes in Eosinophil
Time Frame: 12weeks
Eosinophil was measured in study visit 1(0 week) and visit 3(12 week).
12weeks
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).
12weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonbuk National University Hospital

Investigators

  • Principal Investigator: Baek-Hwan Cho, MD., PhD, Chonbuk National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

July 21, 2011

First Submitted That Met QC Criteria

July 25, 2011

First Posted (Estimate)

July 26, 2011

Study Record Updates

Last Update Posted (Estimate)

November 22, 2012

Last Update Submitted That Met QC Criteria

November 21, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SunChang-TCKJ-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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