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NCT Number: NCT01402141

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

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

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Key information

Conditions

Healthy Subjects Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chungkookjang

Dietary Supplement

Chungkookjang(35g/say)for 12 weeks

Placebo

Dietary Supplement

Placebo(35g/day) for 12 weeks

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

Efficacy and Safety of Chungkookjang, a Fermented Soy Paste, on Histamine-induced Wheal Size

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 26, 2011
Registry last updated
Nov 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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