Efficacy and Safety of Jingling Oral Liquid for Children With ADHD: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Objective: This study aims to verify the therapeutic efficacy and safety of a traditional Chinese medicine, Jingling Oral Liquid, in treating ADHD through a multicenter, randomized, double-blind, placebo-controlled trial (ChiCTR-IPR-17012293). Method: Eighty-five children with ADHD underwent 8 weeks of strictly monitored treatment. Forty children (8.2 ± 2.1 years old, nine girls) were randomly assigned to be treated with Jingling Oral Liquid (Liaoning Dongfangren Pharmaceutical Co., Ltd.), and 41 children (8.6 ± 2.5 years old, six girls) received placebo treatment. Results: Significant improvement was observed in the total score of ADHD rating scale (−4.8, 95% CI [−8.4, −1.1], p = .011) and in the hyperactivity/impulsivity score (−3.0, 95% CI [−4.8, −1.1], p = 0.002) for the Medicine group compared with the Placebo group, but not for inattention score (−1.9, 95% CI [−4.0, 0.2], p = 0.078). No significant changes were observed in the physiological indicators of the children pre- and post-treatment, and no definite drug-related adverse reactions were reported. Conclusion: Jingling Oral Liquid has shown efficacy in managing ADHD, specifically targeting hyperactivity and impulsivity symptoms, and maintaining a favorable safety profile.