Phase 3
Completed N=60
A Human Trial to Evaluate the Effects of Chungkookjang on Histamine-induced Wheal Size in Healthy Subjects
Healthy Subjects
Source: ClinicalTrials.gov NCT01402141 ↗
Enrolled (actual)
60
Serious AEs
—
Results posted
Nov 2012
Primary outcomePrimary: Changes in Histamine-induced Wheal Size — 14.9; 14.9; 14.1; 16.5 mm^2
Summary
The investigators investigate the effect of Chungkookjang on histamine-induced skin reaction in a double-blind, randomized, placebo-controlled, human trial
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Histamine-induced Wheal Size |
14.9; 14.9; 14.1; 16.5 | — |
| 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) |
6; 1 | — |
| SECONDARY Changes in Immunoglobulin E |
73.89; 69.32; 67.32; 62.72 | — |
| SECONDARY Changes in Serum Histamine |
0.56; 0.62; 0.79; 0.80 | — |
| SECONDARY Changes in Interferon-gamma |
14.56; 15.63; 17.57; 18.06 | — |
| SECONDARY Changes in Interleukin-4 |
0.78; 0.55; 0.26; 0.35 | — |
| SECONDARY Changes in Eosinophil |
2.66; 3.30; 2.54; 2.56 | — |
| SECONDARY Changes in Eosinophil Cationic Protein(ECP) |
17.55; 23.53; 19.09; 21.80 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01402141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.