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The investigators investigate the effect of Chungkookjang on histamine-induced skin reaction in a double-blind, randomized, placebo-controlled, human trial
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chungkookjang | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chungkookjang | Dietary Supplement | Chungkookjang(35g/say)for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Immunoglobulin E | Immunoglobulin E was measured in study visit 1(0 week) and visit 3(12 week). | 12weeks |
| Changes in Serum Histamine | Serum histamine was measured in study visit 1(0 week) and visit 3(12 week). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Baek-Hwan Cho, MD., PhD | Chonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | Jeonju | Jeollabuk-do | 560-822 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22136279 | Derived | 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. |
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The criteria were an age from 19 to 80 years, Histamine skin prick test: above 3mm
Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chungkookjang | Chungkookjang(3times/day, 3packs/day, 35g/day) for 12weeks Chungkookjang: The Chungkookjang was manufactured from raw beans, peels made after freeze-drying |
| FG001 | Placebo | Placebo(3times/day, 3packs/day, 35g/day) for 12weeks Placebo : Amount and calorie of placebo are same with Chungkookjang. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chungkookjang(35g) | |
| BG001 | Placebo(35g) | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Histamine-induced Wheal Size | Histamine-induced wheal size was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | mm^2 | 12weeks |
|
|
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Serious and/or other [non-serious] adverse events were not collected/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chungkookjang(35g) | Oral intake Chungkookjang(35g) for 12weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Baek-Hwan Cho, MD | Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | 82-63-250-1579 | chobh@jbnu.ac.kr |
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| ID | Term |
|---|---|
| D014581 | Urticaria |
| ID | Term |
|---|---|
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| C525760 | chungkookjang |
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| Placebo |
| Dietary Supplement |
Placebo(35g/day) for 12 weeks |
|
| 12weeks |
| Changes in Interferon-gamma | Interferon-gamma was measured in study visit 1(0 week) and visit 3(12 week). | 12weeks |
| Changes in Interleukin-4 | Interleukin-4 was measured in study visit 1(0 week) and visit 3(12 week). | 12weeks |
| Changes in Eosinophil | Eosinophil was measured in study visit 1(0 week) and visit 3(12 week). | 12weeks |
| Changes in Eosinophil Cationic Protein(ECP) | Eosinophil Cationic Protein(ECP) was measured in study visit 1(0 week) and visit 3(12 week). | 12weeks |
Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Changes in Immunoglobulin E | Immunoglobulin E was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | IU/mL | 12weeks |
|
|
|
| Secondary | Changes in Serum Histamine | Serum histamine was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | μg/g creatinine | 12weeks |
|
|
|
| Secondary | Changes in Interferon-gamma | Interferon-gamma was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | IU/ml | 12weeks |
|
|
|
| Secondary | Changes in Interleukin-4 | Interleukin-4 was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | pg/ml | 12weeks |
|
|
|
| Secondary | Changes in Eosinophil | Eosinophil was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | Percentage of WBCs(white blood cells) | 12weeks |
|
|
|
| Secondary | Changes in Eosinophil Cationic Protein(ECP) | Eosinophil Cationic Protein(ECP) was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | μg/L | 12weeks |
|
|
|
| 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. | per protocol analysis | Posted | Number | participants | 12weeks |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo(35g) | Oral intake placebo(35g/day) for 12weeks | 0 | 0 | 0 | 0 |
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| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |