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Evidence-based Clinical Research of Jingling Oral Liquid

A multicenter, randomized, double blind, placebo-controlled clinical trial on the efficacy and safety of Jingling oral liquid in the treatment of attention deficit hyperactivity disorder (ADHD)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17012293
Enrollment
Unknown
Registered
2017-08-08
Start date
2014-10-01
Completion date
Unknown
Last updated
2023-06-18

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

Group 1:Jingling oral liquid
Group 2:Placebo

Sponsors

Beijing Anding Hospital of Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 16 Years

Inclusion criteria

Inclusion criteria: (1) meet the diagnostic criteria of ADHD in DSMIV inpatient or outpatient; (2) Aged 6 to 16 years of age, male or female, weight more than 20Kg; (3) the ADHDRS-IV-Parent:lnv score of boys is no less than 25 points, and of girls is no less than 22 points, or in the first and second interviews, the scores of the subtypes they diagnosed are greater than 12. In addition, in the first and second interviews, CGI-S score more than 4 points; normal IQ (WIS score = 75 points); (4) the legal guardian shall sign the informed consent prior to the trial; the person aged 7 and over should sign the informed consent of the child.

Exclusion criteria

Exclusion criteria: (1) there are serious internal diseases such as heart, liver, kidney, glaucoma, prostatic hypertrophy, endocrine and so on. Or there are epilepsy, mental retardation and other neuropsychiatric diseases; (2) tic disorder was diagnosed; (3) the researchers believe that there is an abnormal clinical and laboratory examination; (4) participated in clinical trials of other drugs in the first 3 months; (5) allergic to the spirit of oral liquid or static ling oral liquid capsule; (6) receiving systematic psychotherapy at the same time; (7) 2 weeks before admission, monoamine oxidase inhibitors (MAOI), antipsychotics, antidepressants and mood stabilizers were used; (8) had significantly enhanced the activity of the sympathetic system of somatic diseases (such as catecholamine secreting tumor, or nervous) daily medications to sympathetic nerve activity (such as albuterol inhalation aerosol, pseudo pilocarpine). (9) the researchers believe that other comorbid diseases or medications being taken may interfere with the safe use of the oral capsule; (10) at any stage of the study, psychotropic substances other than experimental drugs should be taken, including what the researchers consider to be active in the central nervous system [such as melatonin (Nao Baijin)]. (11) suspected or indeed a history of alcohol or substance abuse; (12) a woman who explicitly or suspects pregnant; (13) the researchers felt that the parents and guardians of the subjects and / or subjects were unable to fully understand the study or follow the requirements of the study

Design outcomes

Primary

MeasureTime frame
ADHDRS IV-Parent;

Secondary

MeasureTime frame
CPRS-R:S;CGI-S;CGI-I;

Countries

China

Contacts

Public ContactZheng Yi

Beijing Anding Hospital of Capital Medical University

carol-song@qq.com+86 136 8056 7859

Outcome results

None listed

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