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Observation of Clinical Efficacy of Jiawei Kaixin San for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Study of Its Antioxidant Stress Mechanism.

Kai Xin San: Development of a New Formulation for the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) within the Hospital Setting.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000502
Enrollment
Unknown
Registered
2026-03-11
Start date
2025-01-06
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

ADHD

Interventions

Observation group:Flavored Happy Powder
Control Group:Tomoxetine Hydrochloride

Sponsors

Henan University of Traditional Chinese Medicine First Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 16 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for ADHD as per DSM-5; 2. Meets the diagnostic criteria for Attention-Deficit/Hyperactivity Disorder (ADHD) with TCM syndromes of Heart-Spleen Deficiency or Spleen Deficiency with Liver Exuberance; 3. Aged between 6 and 16 years, gender; 4. No use of medications that may affect the trial and no participation in other clinical trials within the past two weeks; 5. Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients clearly diagnosed with epilepsy, autism, chorea, athetosis, intellectual disability, or hepatolenticular degeneration, and those with autoimmune diseases; 2. ADHD caused by other medications or ADHD that has not been clearly defined; 3. Patients with severe organic lesions, genetic metabolic diseases, or infectious diseases; 4. Patients known to be allergic to the investigational drug in this study; 5. Patients who are unable to adhere to the treatment; 6. Other patients deemed unsuitable for clinical trials by the investigator.

Design outcomes

Primary

MeasureTime frame
Swanson, Nolan, and Pelham, Version IV Scale;

Secondary

MeasureTime frame
Traditional Chinese Medicine (TCM) Syndrome Scale;Attention Assessment Scale;

Countries

China

Contacts

Public ContactRongyi Zhou

Henan University of Traditional Chinese Medicine First Affiliated Hospital

zhourongyitcm@sina.com+8615036110898

Outcome results

None listed

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