Comparison of Methylphenidate with the Combanition of Methylphenidate with Crocus sativus ( saffron) in the treatment of ADHD

Comparison of Methylphenidate with the Combanition of Methylphenidate (MPH) and Crocus sativus (Saffron) in the treatment of children and adolescents with Attention-Deficit Hyperactivity Disorder (ADHD): a Randomized, Double Blind Clinical Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190602043790N2

Enrollment

Registered

2020-06-27

Start date

2020-06-21

Completion date

Unknown

Last updated

2020-07-13

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 disorder, unspecified type

Interventions

Intervention 1: Intervention group 1:The first group was treated with (MPH): The first group for 8 weeks uses10 -30 mg/d of Methylphenidate tablet (Created by Poorsina Pharmaceutical Company) depende

Eligibility

Sex/Gender

All

Age

6 Years to 16 Years

Inclusion criteria

Inclusion criteria: Diagnosis of attention-deficit-hyperactivity disorder based on diagnostic and Statistical Manual of Mental Disorders (DSM) Lack of mental retardation No use of Methylphenidate and Crocus sativus (saffron) before the study

Exclusion criteria

Exclusion criteria: Parent's dissatisfaction to participate in study Psychiatric comorbidities (except for oppositional defiant disorder) Drug allergy

Design outcomes

Primary

Measure	Time frame
Hyperactivity symptoms. Timepoint: At the first of study (before the intervention), 4 and 8 week after starting taking Methylphenidate in first group and combined Methylphenidate with Saffron in second group, Attention-Deficit Hyperactivity symptoms are evaluated. Method of measurement: Parent and Teacher Rating of Attention Deficit/Hyperactivity Disorder (ADHD-RS-IV).;Attention-Deficit symptoms. Timepoint: At the first of study (before the intervention), 4 and 8 week after starting taking Methylphenidate in first group and combined Methylphenidate with Saffron in second group, Attention-Deficit Hyperactivity symptoms are evaluated. Method of measurement: Parent and Teacher Rating of Attention Deficit/Hyperactivity Disorder (ADHD-RS-IV).;Impulsivity. Timepoint: At the first of study (before the intervention), 4 and 8 week after starting taking Methylphenidate in first group and combined Methylphenidate with Saffron in second group, Attention-Deficit Hyperactivity symptoms are evaluated. Method of measurement: Parent and Teacher Rating of Attention Deficit/Hyperactivity Disorder (ADHD-RS-IV).	—

Measure

Time frame

Hyperactivity symptoms. Timepoint: At the first of study (before the intervention), 4 and 8 week after starting taking Methylphenidate in first group and combined Methylphenidate with Saffron in second group, Attention-Deficit Hyperactivity symptoms are evaluated. Method of measurement: Parent and Teacher Rating of Attention Deficit/Hyperactivity Disorder (ADHD-RS-IV).;Attention-Deficit symptoms. Timepoint: At the first of study (before the intervention), 4 and 8 week after starting taking Methylphenidate in first group and combined Methylphenidate with Saffron in second group, Attention-Deficit Hyperactivity symptoms are evaluated. Method of measurement: Parent and Teacher Rating of Attention Deficit/Hyperactivity Disorder (ADHD-RS-IV).;Impulsivity. Timepoint: At the first of study (before the intervention), 4 and 8 week after starting taking Methylphenidate in first group and combined Methylphenidate with Saffron in second group, Attention-Deficit Hyperactivity symptoms are evaluated. Method of measurement: Parent and Teacher Rating of Attention Deficit/Hyperactivity Disorder (ADHD-RS-IV).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaba Hasanvandi

Khoram-Abad University of Medical Sciences

s.hasanvandi@alzahra.ac.ir+98 66 3324 2643

Outcome results

None listed

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