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A retrospective study of the clinical effect of Dachaihu decoction on alleviating autism spectrum disorder in children

Traditional Chinese medicine Dachaihu decoction ameliorates abnormal behavior through regulating gut microbiota and metabolites in children with ASD

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2024000353
Enrollment
Unknown
Registered
2024-09-02
Start date
2024-10-02
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

ASD

Interventions

DCH:The related indicators of children with autism were observed at three time points: traditional rehabilitation training and integrated Chinese and western rehabilitation treatment with no Dachaihu
traditional rehabilitation training and integrated Chinese and westernt rehabilitation treatment with Dachaihu decoction intervention for 3 months
traditional rehabilitation training and integrated Chinese and western rehabilitat

Sponsors

The Fifth Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. Age 2-6 years old; 2. The guardian fully understands the research content of the project and voluntarily signs the informed consent form; 3. Children with autism who meet DSM-5 ADI-R ADOS-2 and have been diagnosed with autism by a neuropsychologist with clinical diagnosis qualifications; 4. Children who have not received any rehabilitation treatment before the study; 5. Children who have received traditional rehabilitation training (e.g. applied behavior analysis structured teaching methods sensory integration training etc.) and traditional Chinese and Western medicine rehabilitation (e.g. TMS TDCS acupuncture etc.) during the treatment.

Exclusion criteria

Exclusion criteria: 1. Children who have received traditional rehabilitation training (e.g. applied behavior analysis structured teaching methods sensory integration training etc.) and traditional Chinese and Western medicine rehabilitation (e.g. TMS TDCS acupuncture etc.) during the treatment process; 2. Children who have taken drugs that may directly affect the intestinal flora within 3 months before the study such as traditional Chinese medicine decoction antibiotics probiotics other western medicines (such as risperidone and aripiprazole etc.); 3. Children who have drugs other than traditional Chinese medicine decoction that may directly affect the intestinal flora such as antibiotics probiotics other western medicines (such as risperidone and aripiprazole etc.) during the study period .

Design outcomes

Primary

MeasureTime frame
ABC;ADI-R; ADOS;

Secondary

MeasureTime frame
fNIRS;Food Intolerance;EGG;DSM-5;

Countries

China

Contacts

Public ContactPengya Feng

The Fifth Affiliated Hospital of Zhengzhou University

fengpy@zzu.edu.cn18719816628

Outcome results

None listed

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