The Trial of Effectiveness and Safety of Jingning Granules in the treatment of Attention Deficit Disorder with Hyperactivity
- Conditions
- Attention Deficit Disorder with Hyperactivity
- Registration Number
- ITMCTR2200005612
- Lead Sponsor
- Dongzhimen Hospital, Beijing University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
A. Current symptoms consistent with Western medical criteria for the diagnosis of attention deficit hyperactivity disorder.
B. Current symptoms meet the diagnostic criteria of TCM on the evidence of ADHD in children.
C. Age 5 to 14 years (inclusive), gender not limited.
D. The subject himself/herself or his/her guardian has the will to participate in the treatment as required; if the subject is incapable of civil behavior, the written informed consent of his/her guardian shall be obtained; if the subject is a person with restricted civil behavior, the written informed consent of the subject and his/her guardian shall be obtained.
Those meeting one of the following criteria were excluded.
A. Have childhood schizophrenia, mood disorders, developmental delays, autism, epilepsy, etc. and other psychiatric psychological disorders.
B. Those who were unable or unwilling to cooperate, or whose compliance, in the opinion of the investigator, was likely to be low, such as those with significant somatic and neurological abnormalities, or significant hearing or vision impairment.
C. Combination of other serious cardiovascular, hepatic, renal, neurological, hematopoietic, endocrine, and genetic C. Combination of other serious cardiovascular, cerebrovascular, hepatic, renal, neurological, hematopoietic, endocrine and genetic diseases or malignant tumors
D. Allergic individuals.
E. Those who have participated in other clinical trials within one month or have been treated with other drugs of the same type, such as those with related therapeutic effects or those with antagonistic effects. E. Those who have participated in other clinical trials within one month or have been treated with other drugs of the same type, such as those who have taken drugs with related therapeutic effects or drugs with antagonistic effects, making it difficult to judge the efficacy of drugs.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Chinese version of Swan-son Nolan and Pelham, Version IV Scale-parent form, SNAP-IV;
- Secondary Outcome Measures
Name Time Method Raven's Standard Progressive Matrices, SPM;the evaluation traditional Chinese medicine syndrome;Continuous Performance Test, CPT;parent symptom questionaire, PSQ;