Clinical Study on Traditional Chinese Medicine Five-Tone Therapy for Children with Comprehensive Developmental Delay
Early Phase 1
Recruiting
- Conditions
- global developmental delay,GDD
- Registration Number
- ITMCTR2024000019
- Lead Sponsor
- The Third Affiliated Hospital of Zhengzhou University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1. Age 1 to 5 years old, any gender.
2. Meet the diagnostic criteria for GDD in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
3. Gesell Developmental Diagnosis Scale developmental quotient between 25 and 75.
4. Informed consent from the family members of the child.
Exclusion Criteria
1. Any other severe physical or mental disorders that may cause disruption of brain function.
2. Documented history of head injury.
3. Use of drugs causing cognitive impairment within the month prior to enrollment.
4. Presence of epilepsy.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CITSEA;Achenbach Child Behavior Scale (CBCL) Assessment;infant-junior middle school students' social-Life abilities scale;Gesell Developmental Diagnostic Scale;
- Secondary Outcome Measures
Name Time Method