| Abstrakt: |
This randomised, double-blind, cross-over comparison study investigated the effect of chrysanthemum flower oil (CFO) on diet-induced serum uric acid elevation (DUE). Twenty Japanese male subjects (aged 30–60 years) were randomly divided into two groups. During Period I, one group received the purine-loading food followed by the placebo, and the other received CFO instead of placebo. During Period II, after a wash-out period, the test was repeated and the subjects crossed over to the alternate treatment. Blood was collected at 0, 60, 120, 180 and 240 min after purine loading to measure serum uric acid (sUA) level. Urine was collected from 0 to 120 min. All 20 subjects completed the study, but one subject, with suspected occult blood in his urine at the time of screening and a particularly large difference in urine volume between Periods I and II, was excluded from the efficacy analysis population. In the efficacy analysis population, CFO did not suppress DUE in subjects with baseline sUA between 5.5 and 8.0 mg/dl. However, stratification analysis revealed a statistically significant reduction in DUE by CFO in subjects with baseline sUA ≥7.1 mg/dl. The area under the concentration curve from 0 to 240 min tended to decrease in the same population. For safety analysis, all 20 subjects were evaluated. One patient who developed mild cold symptoms recovered quickly with the symptoms disappearing. No clinically important adverse events were observed. It was concluded that CFO is effective in reducing DUE in Japanese male subjects. |
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