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Clinical efficacy of Kaixin Ningshen Powder on Tic disorders in children from the perspective of general medicine

Clinical efficacy of Kaixin Ningshen Powder on Tic disorders in children from the perspective of general medicine

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068594
Enrollment
Unknown
Registered
2023-02-24
Start date
2022-11-07
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

Tic disorders

Interventions

Kaixin Ningshen Powder Group:Kaixin Ningshen Powder + Health management model of traditional Chinese medicine general practice
control group:Health management model of traditional Chinese medicine general practice

Sponsors

Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1) Children with tic disorders who meet the Western medicine diagnostic criteria for Tic disorders in the fifth edition of the American Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and the "13th Five-Year Plan" "Pediatrics of Traditional Chinese Medicine" (edited by Ma Rong, China Traditional Chinese Medicine Press, 2016.08.4th edition) and "Guidelines for the Diagnosis and Treatment of Common Pediatric Diseases of Traditional Chinese Medicine" Chinese medicine diagnostic standards; (2) Children between the ages of 5 and 12, both male and female; (3) Have not taken traditional Chinese medicine,western medicine and external medicine related to the disease before 2 weeks of this clinical observation; (4) The child can cooperate with and adhere to the treatment of oral Chinese medicine granules; (5) Voluntarily participate in this study, subject and parent or guardian agree and sign informed consent./

Exclusion criteria

Exclusion criteria: (1) Children with transient Tic disorders and refractory Tic disorders; (2) For involuntary movements that can be explained by other diseases, such as rheumatic chorea, Huntington's disease, Wilson's disease, athetosis, myoclonus, acute dyskinesia, convulsive seizures of hysteria, epilepsy and schizophrenia in children, drug-derived extrapyramidal symptoms and other extrapyramidal diseases; (3) Those who have serious primary diseases, psychiatric diseases, acute infectious diseases such as heart, liver, kidney and hematopoietic systems, and need to take other drugs for a long time; (4) Those who are allergic to the test drug or its components, participate in other clinical trials during the test cycle, and are deemed inappropriate by the clinician.

Design outcomes

Primary

MeasureTime frame
Yale global tic severity scale;

Secondary

MeasureTime frame
Quantitative standard table for grading symptoms and signs based on TCM syndromes;

Countries

China

Contacts

Public ContactDong Guo

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

qlyp@sdutcm.edu.cn13767457417

Outcome results

None listed

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