| Abstract |
【Abstract】0bjective Evaluate the effectiveness and safety of using Huizhisu in children with attention deficit hyperactivity disorder (ADHD). Methods A total of 61 children participated and 52 children completed the 8-week visit. The age range is 6-13 years old, with an average of 8.73 ± 2.069. The ADHD Rating Scale IV: Parent Version and Clinical Global Impression(CGI) were used to compare and evaluate the efficacy during the baseline period, treatment 2 weeks, and 8 weeks. At the same time, Conduct safety evaluations during the baseline period and the 8 weeks. The method of taking Huizhisu is as follows: for children under 12 years old, the dosage of Huizhisu is 2g/d (1g/pack), taken in two doses; The dosage for children aged 12 and above is 2g/d, taken in two doses, 2g early and 2g late. Results A total of 61 children participated in this study, and 52 children completed the 8-week visit. The age range is 6-13 years old, with an average of 8.73 ± 2.069 years old. According to the ADHD Rating Scale IV: Parent Version measurement, after using Huizhisu for B2 weeks, the total score, attention deficit score, and hyperactive impulse score of 52 samples decreased significantly compared to before use (t=9.629, p<0.001; t=10.652, p<0.001; t=6.580, p<0.001). After 8 weeks, the total score, attention deficit score, and hyperactive impulse score of the scale decreased compared to the baseline period (t=10.827, p<0.001), p<0.001；t=10.303，p<0.001；t=8.552，p<0.001）。 Compared with 2 weeks of use, the scores of each scale decreased significantly (t=5.590, p<0.001; t=4.689, p<0.001; t=4.905, p<0.001). The CGI scale observed an improvement in disease severity after 2 weeks of use (t=5.814, p<0.001), and a decrease compared to the baseline period at 8 weeks of use (t=9.234, p<0.001). The overall efficacy evaluation showed a statistically significant difference in efficacy between 8 weeks of use and 2 weeks of use (t=6.33, p<0.001). No clinically significant changes in physical signs or laboratory tests were found in the 52 samples, and no adverse reactions were reported in any cases. Conclusion After using Huizhisu B on children with ADHD, it showed positive effects, high safety, and no other side effects, making it safe to use. In this experiment, Huizhisu B showed a positive effect on the symptoms of ADHD in children, with high safety and safe use. Huizhisu B may become another option for auxiliary intervention in children with ADHD. Subsequent double-blind controlled studies can be conducted on this basis.
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