Safety and efficacy of Shaoma Zhijing granule in the treatment of tic disorder in children: a multicenter phase IV clinical trial
- Conditions
- Tic Disorder
- Registration Number
- ITMCTR2200005755
- Lead Sponsor
- Jiangsu Hospital of traditional Chinese Medicine, Beijing Anding Hospital Affiliated to Capital Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1.Meet the diagnostic criteria of Western medicine for tic disorder in children, including Tourette syndrome and chronic tic disorder;
2.TCM syndrome differentiation belongs to the syndrome of liver hyperactivity, wind movement and internal disturbance of phlegm and fire;
3.Age = 5 years old and = 18 years old, regardless of gender;
4.The guardians of the children agree to participate in this study and sign the informed consent form. At the same time, the children = 8 years old need to sign the informed consent form together.
1. Complicated with serious diseases such as heart, brain, liver, kidney or hematopoietic system; Children with clinically significant ECG abnormalities assessed by the investigator;
2. Abnormal liver and kidney function (ALT or AST = 1.2 times the upper limit of normal value, Cr > the upper limit of normal value);
3. Children who have been clearly diagnosed as depression and schizophrenia at the time of screening;
4. Chinese and Western drugs regularly used for the treatment of tic disorder in children within the first two weeks of screening;
5. Children allergic to Shaoma Zhijing granule and its components;
6. The researcher considers it inappropriate to participate in the clinical trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method YGTSS;
- Secondary Outcome Measures
Name Time Method TCM syndrome curative effect;