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Optimization of the Clinical Protocol for Treating Children with Autism Spectrum Disorder Based on the Combination of Disease Manifestation and Syndrome Differentiation in Traditional Chinese Medicine

Optimization of the Clinical Protocol for Treating Children with Autism Spectrum Disorder Based on the Combination of Disease Manifestation and Syndrome Differentiation in Traditional Chinese Medicine

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089258
Enrollment
Unknown
Registered
2024-09-04
Start date
2024-06-14
Completion date
Unknown
Last updated
2024-09-09

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

Conditions

Childhood Autism Spectrum Disorder (ASD)

Interventions

Deficiency of Liver and Kidney Syndrome Group:Modified Liuwei Dihuang Pills
Obstruction of Heart Orifices by Phlegm Syndrome Group:Modified Ditan Tang
Deficiency of Heart and Spleen Syndrome Group:Modified Guipi Tang
Hyperactivity of Heart and Liver Fire Syndrome Group:Modified Daochi Powder combined with Longdan Xiegan Decoction
Routine Rehabilitation Training Group: Routine Rehabilitation Training

Sponsors

The First Affiliated Hospital of Hunan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 18 Years

Inclusion criteria

Inclusion criteria: (1) Those who meet the diagnostic criteria for autism spectrum disorder and the criteria for syndrome differentiation in traditional Chinese medicine; (2) Aged 2 to 18 years; (3) The subjects (aged ?8 years) and their legal guardians must be informed about the study and sign the informed consent form. Only those who meet all the above conditions can be included in this study.

Exclusion criteria

Exclusion criteria: (1) Those with severe primary diseases affecting the cardiovascular, cerebrovascular, kidney, lung, liver, or hematopoietic system; (2) Those with other psychiatric diseases; (3) Those allergic to the drugs used in the trial; (4) Those who are currently participating in other drug trials; (5) Those with poor compliance during the screening period; (6) Those who do not sign the informed consent form. If any of the above conditions is not met, the subject cannot be included in this study.

Design outcomes

Primary

MeasureTime frame
Serum Proteomics;Transcriptomics;Urinary Metabolomics;Fecal Metabolomics;

Countries

China

Contacts

Public ContactDi Zhang

The First Affiliated Hospital of Hunan University of Chinese Medicine

2655357548@qq.com+86 139 0748 0212

Outcome results

None listed

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