Tic disorder
Conditions
Interventions
Low dose group:Administer a certain dose of XEAS and placebo three times a day according to age groups: XEAS 10g+5g placebo for ages = 4 and = 6 years
Age>6 years and = 10 years, 15g+5g placebo
Age>10 years and = 16 years, 20g/time+5g placebo
High dose group:Administer a certain dose of XEAS three times a day according to age group: XEAS15g for ages = 4 and = 6 years old
20g for ages>6 and = 10
25g for ages>10 and = 16
placebo group:Administer a certain dose of placebo three times a day according to age group: 15g/time for = 4 years and = 6 years
Age>6 years and = 10 years, 20g/time
Between the ages of 10 and 16, 25g per session
Sponsors
Shenzhen TCM Hospital
Eligibility
Sex/Gender
All
Age
4 Years to 16 Years
Inclusion criteria
Inclusion criteria: 1) After distinguishing and ruling out the possibility of other diseases through electroencephalogram, psychological testing, and laboratory examination, according to the diagnostic criteria for Tourette Syndrome in the 2013 American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) [3], TTD, CTD, or TS were diagnosed; 2) The traditional Chinese medicine syndrome differentiation is characterized by spleen deficiency, phlegm accumulation, and wind phlegm disturbance; 3) Age = 4 and = 16 years old, gender not limited; 4) YGTSS total score = 25 points; 5) Children aged = 8 and their legal guardians shall jointly sign the informed consent form, while children under 8 years old shall have their legal guardians sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with TTD with a disease course of no more than 90 days (TTD with a disease course of more than 90 days can be enrolled); 2) Non autonomous exercisers who can be explained by other diseases, such as rheumatic chorea, Huntington's disease, Wilson's disease, hand foot hyperkinesia, muscle spasms, acute motor disorders, hysterical spasms, epilepsy, and drug-induced extrapyramidal disorders, as well as substance or drug-induced motor disorders, muscle tone disorders, etc; 3) Combine comorbidities such as Attention Deficit Hyperactivity Disorder (ADHD), Obsessive Compulsive Behavior/Disorder (OCB/OCD), Learning Disorders, Sleep Disorders, Emotional Disorders, and Self Injury Behavior; 4) Diagnosed with depression and schizophrenia during screening; 5) Received medication with indications for treating tic disorders or effective treatment for tic disorders within 14 days prior to randomization, including but not limited to haloperidol, Jiuwei Xifeng granules, etc; 6) Patients who have received sufficient and standardized treatment with two or more anti TD drugs with different mechanisms of action for more than one year but have not shown significant efficacy and have been delayed in recovery; 7) Patients undergoing behavioral therapy can be enrolled after elution; 8) Individuals who are allergic to experimental drugs or excipients; 9) Have participated in or are currently participating in clinical trials of other drugs within 90 days prior to enrollment or within 5 half lives of the investigational drug (whichever is longer); 10) Patients with severe diseases of the heart, brain, liver, kidney, or hematopoietic system, whose levels of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) exceed 2.5 times the upper limit of normal, whose levels of alkaline phosphatase (ALP) or total bilirubin exceed 2 times the upper limit of normal, and whose electrocardiograms have clinical significance as assessed by researchers; 11) According to the researcher's judgment, there are other situations that are not suitable for inclusion in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| YGTSS-TTS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Syndrome Score;C&A-GTS-QoL; | — |
Countries
CHINA
Contacts
Public ContactJingyu Qiu
Shenzhen TCM Hospital
Outcome results
None listed