Investigating the effect of Violet syrup as an subsidiary treatment for insomnia in children with attention deficit hyperactivity disorder

Investigating the effect of Violet syrup as an subsidiary treatment for insomnia in patients with attention deficit hyperactivity disorder treated with Ritalin. In a double-blind clinical trial study in children 6-12 years

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230930059556N1

Enrollment

Registered

2024-02-13

Start date

2022-11-22

Completion date

Unknown

Last updated

2024-03-06

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

Conditions

Attention deficit hyperactivity disorder. Attention-deficit hyperactivity disorders

Interventions

Intervention 1: Intervention group: In 30 patients with attention deficit hyperactivity disorder aged 6 to 12 years who are treated with Ritalin, Banafshe syrup of Kimiagar company is prescribed with

Eligibility

Sex/Gender

All

Age

6 Years to 12 Years

Inclusion criteria

Inclusion criteria: Having DSM 5 diagnostic criteria for ADHD Age 6 to 12 years Not taking any medication affecting the mental state at least 2 weeks before the research

Exclusion criteria

Exclusion criteria: Mental retardation The presence of any psychiatric disorder except OCD History of allergy to the drugs used in the study Having a serious medical illness such as heart disease Uncontrolled seizure disorder People who have systolic blood pressure above 125 mm Hg or their resting pulse is less than 60 or more than 115 beats per minute. Weight under 5 13 kg

Design outcomes

Primary

Measure	Time frame
Sleep score based on Child Sleep Habits Questionnaire (CSHQ). Timepoint: At the beginning of the study (before the intervention) and 4 and 8 weeks after starting to take the drug or placebo. Method of measurement: Children's sleep habits questionnaire.	—

Secondary

Measure	Time frame
Possible side effects of violet syrup. Timepoint: At any time of study. Method of measurement: Patient statement and clinical examination.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSara dehbozorgi

Shiraz University of Medical Sciences

dehbozorgi_s@sums.ac.ir+98 71 3228 7237

Outcome results

None listed

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