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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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003242
Enrollment
Unknown
Registered
2020-04-25
Start date
2020-04-24
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Tic Disorder

Interventions

Sponsors

First Teching Hospital of Tijianjin University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 14 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
YGTSS-TTS scores;

Secondary

MeasureTime frame
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;

Countries

Chian

Contacts

Public ContactLi Xinming

IEC of The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

tjtcmlxm@163.com+86 13902095399

Outcome results

None listed

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