Studying the effect of melatonin on migraine

Phase 3

Recruiting

• Conditions: Migraine Headaches.; Migraine

• Registration Number: IRCT20190107042264N5
• Lead Sponsor: Ahvaz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Confirmation of migraine according to the criteria of the International Headache Society
Chronic migraine patients who are able to distinguish migraine from non-migraine headaches
Patients who do not have primary internal and neurologic complaints, there is no other reason for headache in them
Filling the written consent form to participate in the study
at least 1 year of migraine history

Exclusion Criteria

Severe and debilitating migraine (to eliminate the therapeutic effects of excessive use of painkillers)
Chronic daily headache
Taking drugs other than propranolol to prevent attacks or taking sleeping pills
Migraine Disability Assessment (MIDAS) Grade 4
Treatment-resistant migraine (history of unsuccessful treatment with two or more migraine drug classes)
History of abnormal use of painkillers and Medication Overuse Headache
Significant psychological disorders (psychological illnesses leading to chronic drug use for at least six months)
Pregnancy and breastfeeding
Primary medical conditions and surgeries that require medical interventions (including contraindications to beta-blockers)
Presence of multiple chronic headaches other than migraine with or without medical treatment, such as tension headache
History of melatonin allergy or adverse events
Patient's request to withdraw from the study due to drug side effects or other reasons

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity. Timepoint: 1, 2, 3 and 4 months after start of treatment. Method of measurement: Visual Analog Scale.;Frequency. Timepoint: 1, 2, 3 and 4 months after start of treatment. Method of measurement: Headache Diary.