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The Chinese herbal formula pediatric Anshen Bunao Granules for the treatment of tic disorder: study protocol for a
Wenjing Liu1, Yuchao Luo1, Yuge Cao1
1The Fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen, Guangdong, China.
Background:
Tic disorder (TD) affects 2.68% of children in China. It is classified as a movement disorder, with dysfunction in cortical-striatal-thalamic-cortical circuits implicated in its pathophysiology. Western medical treatments for TD may be associated with adverse reactions and suboptimal adherence in some patients. Pediatric Anshen Bunao Granules (PABG) is an in-house traditional Chinese medicine (TCM) preparation with over 20 years of clinical use for TD, approved by the Guangdong Provincial Drug Administration for use in medical institutions across Guangdong Province. Observational studies have reported effects of PABG; however, high-level evidence remains lacking. This study aims to evaluate the efficacy and safety of PABG in children with TD.
Methods:
This is a randomized, double-blind, active-controlled, parallel-group trial. A total of 150 children aged 4-16 years with TD (TCM syndrome: Spleen Deficiency with Phlegm Accumulation and Wind-Phlegm Disturbance Syndrome) will be recruited from Shenzhen Traditional Chinese Medicine Hospital, Guangdong Province, China. Eligible participants will be stratified by age group and baseline Yale Global Tic Severity Scale (YGTSS) total score, and randomly allocated at a ratio of 2:2:1 to the low-dose PABG group, high-dose PABG group, or active control group (receiving 5% of the active ingredients to maintain blinding) for 8 consecutive weeks of treatment. Primary outcomes will be the change in YGTSS Total Tic Score (YGTSS-TTS) from baseline to Week 8, and the proportion of participants with a ≥ 30% reduction in YGTSS-TTS at Week 8. Secondary outcomes will be assessed using the YGTSS, the TCM Syndrome Rating Scale (TCM-SRS), and the Gilles de la Tourette Syndrome-Quality of Life Scale for Children and Adolescents (C&A-GTS-QoL). Safety assessments will include vital signs, physical examination, laboratory tests, ECG, and adverse events.
Discussion:
This trial will provide evidence on the efficacy and safety of PABG for children with TD. The findings may inform clinical application and potential registration of this in-house TCM preparation.
Clinical Trial Registration:
https://itmctr.ccebtcm.org.cn/, ITMCTR2025001659.