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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01402141
• Other study ID #: SunChang-TCKJ-001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 21, 2011
• Last updated: November 21, 2012
• Start date: October 2010
• Est. completion date: September 2011

Study information

• Verified date: November 2012
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Dietary Supplement:
• Chungkookjang
Chungkookjang(35g/say)for 12 weeks
• Placebo
Placebo(35g/day) for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Histamine-induced Wheal Size	Histamine-induced wheal size was measured in study visit 1(0 week) and visit 3(12 week).	12weeks	Yes
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)	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	Yes
Secondary	Changes in Immunoglobulin E	Immunoglobulin E was measured in study visit 1(0 week) and visit 3(12 week).	12weeks	Yes
Secondary	Changes in Serum Histamine	Serum histamine was measured in study visit 1(0 week) and visit 3(12 week).	12weeks	Yes
Secondary	Changes in Interferon-gamma	Interferon-gamma was measured in study visit 1(0 week) and visit 3(12 week).	12weeks	Yes
Secondary	Changes in Interleukin-4	Interleukin-4 was measured in study visit 1(0 week) and visit 3(12 week).	12weeks	Yes
Secondary	Changes in Eosinophil	Eosinophil was measured in study visit 1(0 week) and visit 3(12 week).	12weeks	Yes
Secondary	Changes in Eosinophil Cationic Protein(ECP)	Eosinophil Cationic Protein(ECP) was measured in study visit 1(0 week) and visit 3(12 week).	12weeks	Yes