Objective To evaluate the efficacy and safety of Jingyi Formula （formula to calm the will） for attention deficit hyperactivity disorder （ADHD） children with spleen-deficiency phlegm-clouding and exuberant heart-liver fire syndrome.Methods Totally 176 ADHD children were randomized into the Jingyi Formula group

Ritalin group and combo therapy group

with 99

37 and 40 in each.The Jingyi Formula group was given both Jingyi Formula granules orally

one dose daily.The Ritalin group was given Ritalin Tablets orally

with a gradual increment of daily total from 5-10mg to less than 40mg and 5 days weekly.The combo therapy group was given Jingyi Formula and Ritalin Tablets with the same dosage and method as above.One treatment course lasted for 3 months and all groups were treated for 2 courses.The TCM syndrome efficacy

attention scores and Conners’ Parent Rating Scale （CPRS） scores were observed before treatment and after 3-month or 6-month treatment.The adverse reaction was recorded.Results The TCM syndrome efficacy in the Jingyi Formula group

Ritalin group and combo therapy group was 79.80%

51.35% and 82.50% after 3-month treatment

while 97.98%

83.78% and 100% after 6-month treatment.The TCM syndrome efficacy in the Jingyi Formula group and combo therapy group was significantly higher than that in the Ritalin group at the same time point （P<0.05 or P<0.01）.The attention scores and CPRS scores were significantly decreased in all groups after 3-month or 6-month treatment （P<0.01）

especially after 6-month treatment （P<0.01）.Comparing with the Ritalin group

the differences of attention scores and impulsiveness scores after 6-month treatment were statistically significant in the Jingyi Formula group and combo therapy group （P<0.05 or P<0.01）.There was no adverse reaction in all groups.Conclusion Jingyi Formula is effective for ADHD children with spleen-deficiency phlegm-clouding and exuberant heart-liver fire syndrome and it can improve the attention with no adverse reaction.