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

First Teching Hospital of Tijianjin University of TCM0 个研究点开始时间: 待定最近更新: 2023年2月20日

试验速览

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•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.

•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.

发起方

First Teching Hospital of Tijianjin University of TCM