Evaluating the Efficacy and Safety of Yi-Gan San in Children and Adolescents With Tourette's Disorder
Condition: Tourette Disorder; Tic Disorders
MeSH terms: Tic Disorders; Tourette Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Yigansan was used in Ming dynasty by Xue Kai as a remedy for restlessness and agitation in
      children. We expect that the total YGTSS scores of Yigansan-treated subjects will be
      significantly reduced compared to that of placebo-treated subjects.
    

Detailed description: 
      Tourette's disorder (TD) is a chronic, childhood-onset neuropsychiatric disorder. It is
      characterized by multiple motor and vocal tics, including involuntary or semivoluntary,
      sudden, brief, intermittent, repetitive movements or sounds. Yigansan was used in several
      clinical trials, like dementia, pervasive developmental disorder, schizophrenia and
      Huntington's disease, with good results. So the investigators choose Yigansan as a Chinese
      medicine formula in this study. After the participants signed the consent form, they have to
      stop taking any Chinese medicine or western medicine for treating Tourette's disorder for two
      weeks and then are randomly assigned to Yigansan group or placebo group. Our hypothesis is
      that Yigansan will be expected to improve motor tics and vocal tics, and YGTSS scores will
      decrease after 4-weeks treatments; secondary outcomes are measured by CGI-TS (Clinical Global
      Impression-Tourette Syndrome) scale and GTS-QOL (The Gilles de la Tourette syndrome-quality
      of life scale), and the investigators will also proceed the basic research of metabolomics
      and biochemistry(GOT、GPT、BUN、Creatinine、K+). In order to ensure the relationship of
      Tourette's disorder and allergic rhinitis, the investigators will detect IgE. Besides, the
      investigators will collect blood and urine from every child or adolescent when a participant
      visits our clinic at week 0 and week 4. In order to find these biomarkers related to TD, the
      investigators will use ELISA kits to detect and quantitate significantly changeable
      concentration of cytokines associated with YGTSS scores. In addition to specific cytokine
      targets, the investigators will also find these metabolites involved in TD between two groups
      before and after taking YGS. The serum and urine samples will be prepared and subjected to
      LC-MS/MS analysis. In summary of the experimental designs and expected results, the therapy
      and background information will be more clarified on the therapeutic efficacy and safety by
      Yigansan treatment for TD. Most importantly, this study will provide a kind of Chinese
      medicine formula to relieve such a disorder that most doctors feel difficult to treat.
    

Intervention name(s): Yigansan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Yigansan granules; One-tenth concentration of Yigansan manufactured to mimic Yigansan granules
Other intervention name(s): YGS; Placebo (for Yigansan)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Yigansan; YGTSS