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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000378
Enrollment
Unknown
Registered
2024-09-04
Start date
2024-10-01
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

Baseline:During the whole trial, the children were treated with traditional rehabilitation training and integrated traditional Chinese and western rehabilitation treatment, and the related samples and
DCH:During the whole trial, the children were treated with DCHD treatment and traditional rehabilitation training integrated traditional Chinese and western rehabilitation treatment, and the related

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
Metabolome of Feces;ADOS;ABC;Metagenome of Feces;Metabolome of serum;DSM-5;Metagenome of Feces;ADI-R;

Secondary

MeasureTime frame
EGG;Food Intolerance;fNIRS;

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