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

Chonbuk National University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Healthy Subjects

Treatments: Dietary Supplement: Chungkookjang; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01402141

SunChang-TCKJ-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Chungkookjang

Experimental group

Treatment:

Dietary Supplement: Chungkookjang

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo