Autistic Spectrum Disorder
Conditions
Interventions
Sponsors
Beijing Anding Hospital Affiliated to Capital Medical
Eligibility
Sex/Gender
All
Age
6 Years to 16 Years
Inclusion criteria
Inclusion criteria: 1. Meet the ASD diagnostic criteria in dsm-5, and also show such behaviors, such as irritability, attack, self injury, or a combination of such behaviors. In addition, the children's Autism Rating Scale (cars) score >= 30; at screening and baseline visits, the subjects' CGI-S score >= 4, and abc-i score >= 18. 2. 6-16 years old, gender unlimited, weight >= 20kg; 3. The legal guardian should sign the informed consent before the experiment; the subjects over 7 years old should also sign the children's informed consent; 4. During the test, environmental factors shall be consistent as much as possible.
Exclusion criteria
Exclusion criteria: 1. There are serious internal diseases such as heart, liver, kidney, glaucoma, prostate hypertrophy, endocrine, etc., or neuropsychiatric diseases such as epilepsy, mental retardation, etc.; 2. Subjects with bipolar disorder, depression, schizophrenia and other mental disorders, and subjects with fragile X-chromosome syndrome; 3. According to the results of medical history or routine mental state examination, there is a significant risk of suicide; the subjects who have had epilepsy before; the subjects who have had severe head injury or stroke; the subjects who have any history of unstable medical disease or are currently ill (such as congenital heart disease, arrhythmia or cancer), the researcher judges that they will be in a major adverse event during the test Under the risk of component (AE), or it may interfere with safety and effectiveness assessment; 4. The researchers think that there are clinical significance of auxiliary examination and laboratory examination abnormalities; 5. Participated in clinical trials of other drugs within 3 months before selection; 6. Be allergic to any component in huizhisu; 7. Receive systematic psychotherapy at the same time; 8. Monoamine oxidase inhibitors (MAOI), antipsychotics, antidepressants and mood stabilizers were used two weeks before admission; 9. Have physical diseases that can significantly enhance sympathetic system activity (such as catecholamine secreting neurotumor), or take drugs that mimic sympathetic activity (such as shuchuanling, inhaled aerosol, pseudopilocarpine) every day; 10. The researchers believe that there are other common diseases or drugs that may interfere with the safe use of huizhisu; 11. At any stage of the study, psychoactive drugs other than the investigational drugs are required, including health care products [such as melatonin (brain platinum)] that the researchers believe have central nervous system activity; 12. Suspect or have a history of alcohol or drug abuse; 13. Women with definite or suspected pregnancy; 14. In the opinion of the investigator, the subjects and / or their parents or guardians could not fully understand the study or follow the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total score of ABC scale and the changes before and after treatment; | — |
Countries
China
Contacts
Public ContactYi Zheng
Beijing Anding Hospital Affiliated to Capital Medical University
Outcome results
None listed