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A multicenter clinical study of Jing Ling Oral Liquid and atomoxetine hydrochloride in the treatment of attention deficit hyperactivity disorder

A multicenter clinical study of Jing Ling Oral Liquid and atomoxetine hydrochloride in the treatment of attention deficit hyperactivity disorder

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067856
Enrollment
Unknown
Registered
2023-01-29
Start date
2023-02-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Attention deficit hyperacitivity disorder

Interventions

TCM treatment group:Jingling Oral Liquid for 3 months
Western medicine treatment group:Tromoxetine hydrochloride for 3 months

Sponsors

Sun Yat-sen Memorial Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: (This study can be considered if all the following conditions are met) 1. Inpatients or outpatients who meet the diagnostic criteria for ADHD in DSM-5; 2. Aged 6-12 years, regardless of gender, weight >= 20 kg; 3. RS lV Parent: Inv score for boys is not less than 25 points, and for girls is not less than 22 points, or the score of the subtype diagnosed in the first and second interviews is greater than 12 points; In addition, in the first and second interviews, CGI-S scores >= 4; Normal IQ (WIS score >= 75); 4. The legal guardian shall sign the informed consent before the test; Subjects aged 8 and above should also sign the children's informed consent form.

Exclusion criteria

Exclusion criteria: 1. Have more serious heart, liver, kidney, glaucoma, prostate hypertrophy and other medical diseases; Or have epilepsy, mental retardation and other neuropsychiatric diseases; 2. The diagnosis was tic disorder; 3. The researcher thinks that the auxiliary examination and laboratory examination are abnormal with clinical significance; 4. Participated in clinical trials of other drugs within 3 months before enrollment; 5. Allergic to some component in Jingling Oral Liquid; 6. Monoamine oxidase inhibitors (MAOI), antipsychotics, antidepressants and mood stabilizers were used 2 weeks before enrollment; 7. Suffer from somatic diseases that can significantly enhance sympathetic system activity (such as catecholamine secreting neuroma), or take sympathomimetic drugs (such as salbutamol, inhaled aerosol, pseudopilocarpine) every day; 8. The researchers believe that other common diseases or drugs being taken may interfere with the safe use of Jingling Oral Liquid; 9. At any stage of the study, it is necessary to take psychotropic drugs other than the experimental drugs, including health care products that the researchers believe have central nervous system activity (such as melatonin (brain platinum)); 10. Suspected or confirmed history of alcohol and drug abuse; 11. A woman who is clearly or suspected of being pregnant; 12. The researcher believes that the subject and/or the parent or guardian of the subject cannot fully understand the study or comply with the requirements of the study.

Design outcomes

Primary

MeasureTime frame
Total score of RS-w-parent: inv scale for attention deficit-hyperactivity disorder (ADHD) in children and its changes before and after treatment;

Secondary

MeasureTime frame
The scores and changes of Children's ADHD RS-IV-Parent: Inv scale, attention deficit subscale, hyperactivity impulse subscale.;The scores and changes of Conners' Parent Rating Scale-Short Form (CPRS-R);The scores and changes of Clinical Global Impression Scale (CGI-S) and Clinical Global Impression Improvement (CGI-I);

Countries

China

Contacts

Public ContactXiangyang Luo

Sun Yat-sen Memorial Hospital Sun Yat-sen University

luoxy33@139.com+86 13602838578

Outcome results

None listed

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