Clinical efficacy evaluation of Jingxin Zhidong formula in the treatment of moderate and severe Tic Disorder

Not Applicable

Completed

• Conditions: Tic Disorder

• Registration Number: ITMCTR2100004402
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Children with TD who visited the Department of Pediatrics of Guang'anmen Hospital from January 2014 to December 2015;
2. Aged 8-11 years;
3. All meet the requirements of 2000 DSM - ? - TR diagnostic criteria and TCM syndrome differentiation criteria for children with tic disorder (head and body twitch, blinking and pouting, throat cleaning, or frowning and nose shrugging, or corner twitch, or sputum in throat, or abnormal voice, etc.) were discussed When heavy, and see temper irritable, or timid, easy to nervous, or suspicious, or easy to be wronged, or easy to excited, or sleep slowly, or sleep not solid, take food can, stool regulation, tongue light red or red, thin white or white fur, pulse string or slippery string.)
4. The course of disease is more than one year, the Yale Global Tic Severity Scale modified (YGTSS) score is between 40 and 70 (there is no clear diagnostic criteria for refractory tic disorder, the Yale Global Tic Severity Scale modified (YGTSS) score between 40 and 70 is refractory tic disorder), no use of Chinese and Western medicine or 6 months before treatment There was no use of Chinese and Western medicine in three months.
5. All the children were signed by their parents and obtained the informed consent from the medical ethics committee of Guang'anmen Hospital.

Exclusion Criteria

1. Patients with hepatolenticular degeneration, rheumatic chorea, migraine in children, epilepsy and mental retardation;
2. Patients with history of schizophrenia, etc;
3. Patients with history of genetic metabolism;
4. Patients with severe physical diseases;
5. Patients with arrhythmia and abnormal liver and kidney function;
6. Patients with history of drug allergy;
7. Children and their parents do not agree to participate in the treatment.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
YGTSS score;

Secondary Outcome Measures

Name	Time	Method
TCM syndrome rating scale score;Adverse reaction scale score;