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Clinical Study on the Treatment of tic disorders in Children with Xiao'er Chaiqin Qingjie Granules

A randomized multicenter clinical study evaluating the effectiveness and safety of Xiao'er Chaiqin Qingjie Granules in the treatment of tic disorders (external wind induced syndrome) in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000440
Enrollment
Unknown
Registered
2024-09-16
Start date
2024-09-16
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

Tic disorders

Interventions

low dose group:Xiao'er Chaiqin Qingjie Granules, aged 4-6 years, 1.5g each time, aged 7-12 years, 3g each time
Take orally three times a day.
middle dose group:Xiao'er Chaiqin Qingjie Granules, aged 4-6 years, 5g each time, aged 7-12 years, 10g each time
High dose group:Xiao'er Chaiqin Qingjie Granules, aged 4-6 years, 10g each time, aged 7-12 years, 20g each time

Sponsors

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

Eligibility

Sex/Gender
All
Age
4 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria for Tourette's syndrome in children and the differentiation criteria for TCM external wind induced syndrome; (2) Age 4-12 years old; (3) Tic symptoms worsen CGI-GI score = 5 points; (4) No changes in medication plan within 2 weeks prior to diagnosis; (5) The informed consent process should comply with regulations and the legal guardian or the subject child (= 8 years old) should jointly sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Other specific or unspecified tic disorders severe TD and refractory TD; (2) Non autonomous exercisers who can be explained by other diseases such as rheumatic disease Huntington's disease and Wilson's disease Transgender hand foot hyperkinesia muscle spasms acute motor disorders spasms of hysteria childhood schizophrenia and drug-induced pyramidal disorders External diseases; (3) Children with herpetic pharyngitis purulent tonsillitis and pneumonia; (4) Children with a history of epilepsy or febrile seizures; (5) White blood cell count absolute neutrophil count and CRP all exceeded 1.2 ULN and the researchers considered it to be bacterial infection Dye carrier; (6) Within 2 weeks of enrollment have used traditional Chinese medicines that have both the effects of dispelling wind and clearing heat as well as calming wind and stopping spasms; (7) Patients with severe primary diseases of the heart liver kidney digestive and hematopoietic systems; (8) Children who are allergic to known ingredients of the research medication; (9) The patient is unable to cooperate or is currently participating in other drug research; (10) According to the researcher's judgment it is not suitable to be included in the group.

Design outcomes

Primary

MeasureTime frame
YGTSS-TTS;

Secondary

MeasureTime frame
YGTSS-total scores;Clinical Global Impression- Impression scales;YGTSS-phonal scores;YGTSS-Functional impairment scores;Traditional Chinese Medicine Single Symptom Score;YGTSS-motor scores;

Countries

China

Contacts

Public ContactRong Ping

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

erke2007@163.com022-27986353

Outcome results

None listed

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