Clinical Evaluation of the Effectiveness of the Preparation Radelax Kids

Abstract

Objective. Tashkent Medicine academy 4–12 years old in the clinic in children Radelax KIDS (passiflora 150 mg, melissa 100 mg, medicinal chamomile 150 mg, magnesium lactate dihydrate 100 mg [pure Mg 10 mg], pyridoxine 3 mg; 3 ml) sleep quality and anxiety to the signs the impact Evaluation. Methods. Prospective, randomized, controlled, open In the study, 80 children were randomly assigned to a 1:1 ratio. main group (Radelax KIDS, 3 ml in the evening, 30 days) and control group to (sleep hygiene, psychoeducation) were separated. Primary Indications: sleep to leave time (min.), subjective sleep quality scores. Secondary indicators: night awakening frequency, anxiety scale points, parents satisfaction, unpleasant events. Analysis is based on the ITT principle with t - test / χ² and ANCOVA take went. Results. Groups start indicators according to balanced was. On the 30th day the main in the group to sleep to leave time to control relatively −7.3 minutes (95% CI −9.7; −4.9; p<0.001), night awakening frequency with −1.1 times (95% CI −1.4; −0.8; p<0.001) decreased; subjective sleep quality +2.2 points (95% CI +1.6; +2.8; p<0.001) improved. Anxiety points main in the group −6.4, in control −1.6 to the point changed (p< 0.001). Parents ' “very " Satisfactory " rating: 65% (main) vs 25% (control). Negative events in 7.5% of cases light in appearance observed, serious events It didn't happen. Conclusion. Radelax KIDS 30 days during in children to sleep to leave time reduces sleep quality improves, at night awakenings and anxiety signs reduces and good The drug is absorbed. sleep hygiene and psychoeducation with in combination useful assistant tool to be possible. In the future blindly, many centered and long term research necessary.