Evaluating the Efficacy and Safety of Yi-Gan San in Children and Adolescents With Tourette’s Disorder

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Brief Title

Evaluating the Efficacy and Safety of Yi-Gan San in Children and Adolescents With Tourette's Disorder

Official Title

A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Yi-Gan San in Children and Adolescents With Tourette's Disorder

Brief 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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change from Baseline to Week 4 in Yale Global Tic Severity Scale (YGTSS) total tic score (TTS)

Secondary Outcome

 Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 4

Condition

Tourette Disorder

Intervention

Yigansan

Study Arms / Comparison Groups

 Yigansan
Description:  2.5g of Yigansan granules by mouth, three times a day for 4 weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

154

Start Date

June 16, 2018

Completion Date

August 31, 2021

Primary Completion Date

August 15, 2020

Eligibility Criteria

        Inclusion Criteria:

          1. The subject is a male or female child or adolescent, 6 to 17 years of age (inclusive)
             at the time of signing the informed consent/assent.

          2. The subject meets current DSM-V diagnostic criteria for Tourette's Disorder.

          3. The subject has a total score of ≥ 20 on the YGTSS at Screening and Baseline
             (randomization).

          4. Tic symptoms may cause impairment in the subject's normal routines, which include
             academic achievement, occupational functioning, social activities, and/or
             relationships.

          5. Females of childbearing potential (defined by menarche and not having undergone
             surgical sterilization/hysterectomy) must have a negative urine pregnancy test (when
             visiting our clinic at week 0 and week 4).

        Exclusion Criteria:

          1. The subject presents with a clinical presentation and/or history that is consistent
             with another neurologic condition that may have accompanying abnormal movements. These
             include, but are not limited to:

             Transient Tic disorder/ Huntington's disease/ Parkinson's disease/ Sydenham's chorea/
             Wilson's disease/ Mental retardation/ Pervasive developmental disorder/ Traumatic
             brain injury/ Stroke/ Restless Legs Syndrome

          2. The subject has a history of schizophrenia, bipolar disorder, or other psychotic
             disorder.

          3. Subjects who receive psychostimulants for the treatment of ADD/ADHD and who have
             developed and/or had exacerbations of the tic disorder after the initiation of
             stimulant treatment.

          4. Subjects who ever participated in any Chinese medicine or western medicine trial
             within 30 days.

          5. Subjects requiring cognitive-behavioral therapy (CBT) for Tourette's Disorder during
             the trial period.

          6. The inability to swallow Chinese herbal medicine.

          7. Female subjects who have been pregnant.
      

Gender

All

Ages

6 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Cheng-Hao Huang, , 

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations


NCT ID

NCT03564132

Organization ID

CMUH106-REC2-148


Responsible Party

Sponsor

Study Sponsor

China Medical University Hospital


Study Sponsor

Cheng-Hao Huang, Principal Investigator, China Medical University Hospital


Verification Date

July 2021