Effect of propranolol with melatonin on the clinical symptoms in children with migraine

Effect of propranolol with melatonin versus propranolol alone on the clinical symptoms in children with migraine without sleep disorder: a randomized clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120215009014N345

Enrollment

Registered

2020-03-13

Start date

2019-10-07

Completion date

Unknown

Last updated

2020-03-24

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

Conditions

Migraine without sleep disorder. Migraine without aura

Interventions

Intervention 1: Intervention group: Propranolol tablet (manufactured by Razak Pharmaceutical Co.) 1 mg/kg daily for 3 months plus melatonin tablet (manufactured by Razak Pharmaceutical Co.) 3 mg daily

Eligibility

Sex/Gender

All

Age

5 Years to 15 Years

Inclusion criteria

Inclusion criteria: Age of 5 to 15 years Migraine without sleep disorder

Exclusion criteria

Exclusion criteria: Contraindication of propranolol or melatonin

Design outcomes

Primary

Measure	Time frame
Severity of headache. Timepoint: Before the intervention and 1 and 3 months after that. Method of measurement: By using Visual Analog Scale (VAS).;Nausea and vomiting. Timepoint: Before the intervention and 1 and 3 months after that. Method of measurement: By taking history.;Photophobia. Timepoint: Before the intervention and 1 and 3 months after that. Method of measurement: By taking history.;Phonophobia. Timepoint: Before the intervention and 1 and 3 months after that. Method of measurement: By taking history.	—

Measure

Time frame

Severity of headache. Timepoint: Before the intervention and 1 and 3 months after that. Method of measurement: By using Visual Analog Scale (VAS).;Nausea and vomiting. Timepoint: Before the intervention and 1 and 3 months after that. Method of measurement: By taking history.;Photophobia. Timepoint: Before the intervention and 1 and 3 months after that. Method of measurement: By taking history.;Phonophobia. Timepoint: Before the intervention and 1 and 3 months after that. Method of measurement: By taking history.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Paria Abbasian

Hamedan University of Medical Sciences

paria.abbasian.66@gmail.com+98 81 3838 0572

Outcome results

None listed

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