Skip to content

Clinical trial of Xiao'er Chaiqin Qingjie Granules in the treatment of Tic disorders in children

Randomized, single blind, three arm parallel controlled, multicenter clinical trial evaluating the efficacy and safety of Xiao'er Chaiqin Qingjie Granules in the treatment of Tic disorders in children (induced by external wind)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078793
Enrollment
Unknown
Registered
2023-12-19
Start date
2023-12-20
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tic disorders

Interventions

Test group:Xiao'er Chaiqin Qingjie Granules
Control group:Xiao'er Qingqiao Granules
Blank group:None

Sponsors

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 12 Years

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

MeasureTime frame
Yale Global Tic Severity Scale-Total Tic Score;

Secondary

MeasureTime 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

Public ContactPing Rong

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

352768979@qq.com+86 22 2798 6353

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026