NCT01402141

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 12, 2012

Completed
Last Updated

November 22, 2012

Status Verified

November 1, 2012

Enrollment Period

9 months

First QC Date

July 21, 2011

Results QC Date

July 11, 2012

Last Update Submit

November 21, 2012

Conditions

Healthy Subjects

Keywords

Chungkookjanghistamineskin reactionwheal

Outcome Measures

Primary Outcomes (2)

  • Changes in Histamine-induced Wheal Size

    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)

    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 Outcomes (6)

  • Changes in Immunoglobulin E

    12weeks

  • Changes in Serum Histamine

    12weeks

  • Changes in Interferon-gamma

    12weeks

  • Changes in Interleukin-4

    12weeks

  • Changes in Eosinophil

    12weeks

  • +1 more secondary outcomes

Study Arms (2)

Chungkookjang

EXPERIMENTAL
Dietary Supplement: Chungkookjang

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

ChungkookjangDIETARY_SUPPLEMENT

Chungkookjang(35g/say)for 12 weeks

Chungkookjang
PlaceboDIETARY_SUPPLEMENT

Placebo(35g/day) for 12 weeks

Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histamine skin prick test: above 3mm

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

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

Location

Related Publications (1)

  • Kwon DY, Yang HJ, Kim MJ, Kang HJ, Kim HJ, Ha KC, Back HI, Kim SY, Park EO, Kim MG, Yun SK, Chae SW, Cho BH. Influence of the Chungkookjang on histamine-induced wheal and flare skin response: a randomized, double-blind, placebo controlled trial. BMC Complement Altern Med. 2011 Dec 5;11:125. doi: 10.1186/1472-6882-11-125.

    PMID: 22136279DERIVED

MeSH Terms

Conditions

Urticaria

Interventions

chungkookjang

Condition Hierarchy (Ancestors)

Skin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Dr. Baek-Hwan Cho, MD
Organization
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
chobh@jbnu.ac.kr
82-63-250-1579

Study Officials

  • Baek-Hwan Cho, MD., PhD

    Chonbuk National University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Trial Center for Functional Foods

Study Record Dates

First Submitted

July 21, 2011

First Posted

July 26, 2011

Study Start

October 1, 2010

Primary Completion

July 1, 2011

Study Completion

September 1, 2011

Last Updated

November 22, 2012

Results First Posted

November 12, 2012

Record last verified: 2012-11

Locations

KR(1)