Safety and efficacy of Shaoma Zhijing granule in the treatment of tic disorder in children: a multicenter phase IV clinical trial

Jiangsu Hospital of traditional Chinese Medicine, Beijing Anding Hospital Affiliated to Capital Medical University0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•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.

发起方

Jiangsu Hospital of traditional Chinese Medicine, Beijing Anding Hospital Affiliated to Capital Medical University