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Clinical study on interfering the early stage of ADHD with TCM theory of invigorating the kidney function: the efficacy and safety of Yizhiningshen Granules treating ADHD of young children

Clinical study on interfering the early stage of ADHD with TCM theory of invigorating the kidney function: the efficacy and safety of Yizhiningshen Granules treating ADHD of young children

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONRC-13004413
Enrollment
Unknown
Registered
2013-12-06
Start date
2014-04-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Attention Deficit /Hyperactivity Disorder

Interventions

Teatment Group:yizhiningshen granules
Control Group:No intervention

Sponsors

First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 8 Years

Inclusion criteria

Inclusion criteria: 1. meeting the diagnostic criteria of ADHD in Western medicine (WM); 2. meeting the differentiation criteria of kidney essence-deficiency syndrome in TCM; 3. aged 4-8(<9) years; 4. intelligence quotient (IQ) test are within 75 to 99(<100); 5. Within the last two weeks, never use any psychoactive substance,relative Chinese medication, such as Jing-ling Oral Liquid, and nervous stimulant or tricyclic antidepressants like pemoline, amphetamine, and imipramine; 6. Children conforming to the standards above can be incorporated into the study.

Exclusion criteria

Exclusion criteria: 1. simultaneously, suffering from serious organic diseases such as cardiovascular disease, liver disease, kidney disease, the diseases in the hematopoietic system and nervous system, like hyperthyroidism, chronic nephritis, hepatitis, congenital heart disease, infantile chorea, subacute cephalitis, etc.; 2. abnormal Biochemical indexes that can be explained by the studying diseases, such as serum creatinine (Cr), blood urea nitrogen (BUN) and third transaminase (GPT or ALT), aspertate aminotransferase (GOT or AST), urine protein above + + and urinary RBC above+ visual or hearing disorders caused similar ADHD symptoms; 3. Hypophrenia children behave like ADHD children; 4. ADHD symptoms caused by serious psychological or mental diseases, such as slow mental development, pervasive development disorder, childhood schizophrenia, manic episode, bipolar disorder, specific academic skill development disorder and Tourette Syndrome; 5. ADHD symptoms caused by the side effects of various drugs; 6. Allergic constitution (allergic to 2 drugs above) or allergic to the known components of the drugs; 7. Children who cannot cooperate or who are taking part in other drug trial; 8. Children who are judged by doctors to easily be lost in the follow-up; Children conforming to the above any one, can be ruled out.

Design outcomes

Primary

MeasureTime frame
SNAP-IV;

Secondary

MeasureTime frame
Conners ASQ;Attention test;stroop test;CGAS;Neurological soft signs;The scale of TCM syndrom;

Countries

China

Contacts

Public ContactLI Yaping

First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

zf_ts@163.com+86 15222062977

Outcome results

None listed

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