Efficacy and safety of Jiu-Wei-Xi-Feng granules (Longgu replaced by Muli) for treating the mild or moderate Tic Disorders in children: a randomized, double-bind, original formula parallel controlled, multicentric equivalence trial

Phase 1

Recruiting

• Conditions: Tic Disorder

• Registration Number: ITMCTR2000003242
• Lead Sponsor: First Teching Hospital of Tijianjin University of TCM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Meeting the diagnosis criteria of TD of mild or moderate based on DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) and confirmed the TCM syndrome pattern criteria of consumption of renal yin and liver wind stirring up internally syndrome;
2. Aged between 4 and 14 years;
3. The participants TD last for more than a year, and had not used any related therapeutic drugs for TD before 2-4 weeks enrolled (>Six half-lives plus one week for the related drugs).
4. Parents or other legal guardians of the children sign informed consent.

Exclusion Criteria

1. Participant with temporary twitch disorder (TTD), other specific tics or non-specific tics, severe TD, and refractory TD (the TD patients who have been treated with sufficient anti-TD drugs such as tiapride hydrochloride and aripiprazole for more than 1 year without effective and whose course of disease is prolonged).
2. Participants involuntary movement can be explained by other diseases, such as rheumatic dance, Huntington's dance, Kayser's disease, Hammond's disease, myoclonus, acute dyskinesia, spasm of hysteria, epilepsy and childhood schizophrenia, and drug-induced extrapyramidal diseases.
3. Participant combined with other mental disorders such as attention deficit hyperactivity disorder (ADHD), obsessive-compulsive disorder (OCD), learning disorder, sleep disorder, etc.
4. Participant with severe primary diseases of heart, liver, kidney, digestion and hematopoietic system;
5. Participant with allergic reaction to composition of experimental drug;
6. Participant cannot cooperate or is participating in other drug trials;
7. The researcher considered that the participant is not suitable to be enrolled.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
YGTSS-TTS scores;

Secondary Outcome Measures

Name	Time	Method
total scores of YGTSS;CGI-S score;Total effective rate of twitch;Effects of TCM symptoms;Single symptom resolution rate;YGTSS twitch integrals, motor tics and vocal tics' factor scores;