Tic disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for children with tic disorders and the differentiation criteria for external wind induced movement syndrome in traditional Chinese medicine; (2) Age range from 5 to 12 years old; (3) Tic symptoms worsen, with a CGI-GI score of = 5 points; (4) Tic disorders lasts for more than 3 months; (5) Symptoms of upper respiratory tract infection appear for = 48 hours; (6) The informed consent process should comply with regulations, and the legal guardian or co sign the informed consent form with the subject child (= 8 years old).
Exclusion criteria
Exclusion criteria: (1) Other specific or unspecified tic disorders, severe TD, and refractory TD; (2) Individuals with involuntary movements that can be explained by other diseases, such as rheumatic chorea, Huntington's chorea, hepatolenticular degeneration, athetosis, myoclonus, acute motor disorders, spasms of hysteria, childhood schizophrenia, and drug-induced extrapyramidal diseases; (3) Meets the diagnostic criteria for comorbidities such as Attention Deficit Hyperactivity Disorder (ADHD), Obsessive Compulsive Disorder (OCD), Learning Disability, Sleep Disorder, etc; (4) Children with herpetic pharyngitis, purulent tonsillitis, and pneumonia; (5) Children with a history of epilepsy or febrile seizures; (6) The white blood cell count, absolute value of neutrophils, and CRP all exceed 1.2 ULN, and the researchers consider it as a bacterial infection; (7) Individuals with severe primary diseases such as heart, liver, kidney, digestive, and hematopoietic systems; (8) Children who are allergic to known components of the experimental drug; (9) Patients who are unable to cooperate or are currently participating in other drug trials; (10) According to the researcher's judgment, it is not suitable to enroll individuals.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Yale Global Tic Severity Scale-Total Tic Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Yale Global Tic Severity Scale-Total score;Yale Global Tic Severity Scale-Motor Tic Score;Yale Global Tic Severity Scale-Phonic Tic Score;Yale Global Tic Severity Scale-Impairment Score;Clinical Global Impression-Impression scale;Traditional Chinese Medicine Single Symptom Score; | — |
Countries
China
Contacts
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine