Effect of common figs and almonds syrup, sweet almond syrup and methylphenidate in the treatment of attention deficit / hyperactivity disorder

Phase 3

Recruiting

Conditions: Attention-deficit hyperactivity disorder.
Attention-deficit hyperactivity disorder, predominantly inattentive type
F90.0

Registration Number: IRCT20220406054433N1

Lead Sponsor: Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

Children 6 to 14 years old suspected to ADHD
Obtain informed consent from the child's parent or guardian
Diagnosis of ADHD by a psychiatrist
New diagnosis of the disorder and not taking another drug

Exclusion Criteria

Mental retardation IQ <70
Simultaneous use of other methods of alternative and complementary medicine
Having medical conditions including cardiovascular disease, gastrointestinal diseases, epilepsy
Having other mental disorders including schizophrenia
Existence of an organic brain problem
Malnutrition and obvious growth disorders
Recent treatment with antipsychotic drugs
Drug dependence or abuse in the last 6 months
History of allergies to sweet almonds and its products
History of allergies to figs and its products
Simultaneous consumption of other products containing almonds (nuts, almond sweets) and figs
The need for behavioral therapy

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of attention deficit / hyperactivity disorder based on the questionnaire score. Timepoint: At the beginning of the study (before the intervention), 4, 8 and 12 weeks after starting the drug. Method of measurement: Teacher and Parent ADHD rating scale.

Secondary Outcome Measures

Name	Time	Method
Evaluation of drug side effects. Timepoint: Once every 2 weeks after starting treatment. Method of measurement: Checklist of drug side effects and possible side effects based on CTCAE criteria (Common Terminology Criteria for Adverse Events v4.03, 2010).;BMI, and clinical examination results. Timepoint: 4, 8 and 12 weeks after the start of the intervention. Method of measurement: questionnaire.