The purpose of this study is to evaluate the effective and safety of 5LGr in pediatric patients with tic disorders.
5LGr is a kind of traditional Chinese medicine(TCM) which under the direction of TCM theory.The aim of this study is prove the effective and safety of 5LGr in children and adolescence of Tic syndrome sub-population with specific TCM syndrome differentiation, when compared with tiapride and placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
603
Dosage form:Granule Strength:5 gram/sack Dosage:1 sack for patients less than 12 yrs 1.5 sacks for patients 13-18 yrs. Frequency: three times per day. Duration: 8 weeks.
dosage form: tablet Strength:100 mg Dosage: For patients 5-12 yrs: 50mg bid for first 2 weeks, then 100 mg, bid for next 6 weeks; for patients 13-18 yrs:100mg bid for first 2 weeks, then 200 mg bid for next 6 weeks. Total duration:8 weeks.
mimetic granule: same with 5LGr mimetic tablet: same with tiapride
Yale Global Tic Severity Scale(YGTSS) score change from baseline at 8 weeks
The outcome will be assessed at 8th weeks. And patients who judged as effective by investigator will be included in a follow-up period up to 4 weeks.
Time frame: Within 8 weeks of completion intervention.
Change of syndrome scales from baseline at 8 weeks;
Time frame: Within 8 weeks of completion intervention.
Change of YGTSS scores from baseline at 2 weeks;
Time frame: within 2 weeks of intervention
Change of syndrome scales from baseline at 2 weeks;
Time frame: Within 2 weeks of intervention
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