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

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.

Timeline

Start

2018-06-16

Primary completion

2020-08-15

Completion

2022-08-31

Publications

• Background Jankovic J. Tourette's syndrome. N Engl J Med. 2001 Oct 18;345(16):1184-92. doi: 10.1056/NEJMra010032. No abstract available.
• Background Cohen SC, Leckman JF, Bloch MH. Clinical assessment of Tourette syndrome and tic disorders. Neurosci Biobehav Rev. 2013 Jul;37(6):997-1007. doi: 10.1016/j.neubiorev.2012.11.013. Epub 2012 Dec 1.
• Background Wang S, Qi F, Li J, Zhao L, Li A. Effects of Chinese herbal medicine Ningdong granule on regulating dopamine (DA)/serotonin (5-TH) and gamma-amino butyric acid (GABA) in patients with Tourette syndrome. Biosci Trends. 2012 Aug;6(4):212-8. doi: 10.5582/bst.2012.v6.4.212.
• Background Zhao L, Li AY, Lv H, Liu FY, Qi FH. Traditional Chinese medicine Ningdong granule: the beneficial effects in Tourette's disorder. J Int Med Res. 2010 Jan-Feb;38(1):169-75. doi: 10.1177/147323001003800119.
• Background Kim YH, Son CG, Ku BC, Lee HW, Lim HS, Lee MS. Herbal medicines for treating tic disorders: a systematic review of randomised controlled trials. Chin Med. 2014 Feb 7;9(1):6. doi: 10.1186/1749-8546-9-6.
• Background Wu M, Xiao GH, Zhang JM, Zhang X, Ma B, Wang SX, Zhou YB, Zhang JY. Clinical research into Qufeng Zhidong Recipe used to treat 31 children with tic disorder. J Tradit Chin Med. 2010 Sep;30(3):163-70. doi: 10.1016/s0254-6272(10)60034-9.
• Background Chou IC, Lin HC, Lin CC, Sung FC, Kao CH. Tourette syndrome and risk of depression: a population-based cohort study in Taiwan. J Dev Behav Pediatr. 2013 Apr;34(3):181-5. doi: 10.1097/DBP.0b013e3182829f2b.
• Background Zheng Y, Zhang ZJ, Han XM, Ding Y, Chen YY, Wang XF, Wei XW, Wang MJ, Cheng Y, Nie ZH, Zhao M, Zheng XX. A proprietary herbal medicine (5-Ling Granule) for Tourette syndrome: a randomized controlled trial. J Child Psychol Psychiatry. 2016 Jan;57(1):74-83. doi: 10.1111/jcpp.12432. Epub 2015 Jun 13.
• Background Eddy CM, Rickards HE, Cavanna AE. Treatment strategies for tics in Tourette syndrome. Ther Adv Neurol Disord. 2011 Jan;4(1):25-45. doi: 10.1177/1756285610390261.
• Background Takeyoshi K, Kurita M, Nishino S, Teranishi M, Numata Y, Sato T, Okubo Y. Yokukansan improves behavioral and psychological symptoms of dementia by suppressing dopaminergic function. Neuropsychiatr Dis Treat. 2016 Mar 15;12:641-9. doi: 10.2147/NDT.S99032. eCollection 2016.
• Background Miyaoka T, Furuya M, Horiguchi J, Wake R, Hashioka S, Thoyama M, Murotani K, Mori N, Minabe Y, Iyo M, Ueno S, Ezoe S, Hoshino S, Seno H. Efficacy and safety of yokukansan in treatment-resistant schizophrenia: a randomized, multicenter, double-blind, placebo-controlled trial. Evid Based Complement Alternat Med. 2015;2015:201592. doi: 10.1155/2015/201592. Epub 2015 Apr 14.
• Background Miyaoka T, Furuya M, Horiguchi J, Wake R, Hashioka S, Tohyama M, Mori N, Minabe Y, Iyo M, Ueno S, Ezoe S, Murotani K, Hoshino S, Seno H. Efficacy and safety of yokukansan in treatment-resistant schizophrenia: a randomized, double-blind, placebo-controlled trial (a Positive and Negative Syndrome Scale, five-factor analysis). Psychopharmacology (Berl). 2015 Jan;232(1):155-64. doi: 10.1007/s00213-014-3645-8. Epub 2014 Jun 13.

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