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The effect of saffron supplementation in migraine

Investigating the effect of saffron supplementation on inflammatory factors, oxidative stress and severity, frequency, length of headache in women with migraine: A double-blind placebo controlled randomized trial study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20121216011763N65
Enrollment
90
Registered
2025-03-31
Start date
2025-05-31
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Migraine. Migraine

Interventions

Intervention 1: Intervention group: For 8 weeks, daily intake of one tablet containing 100 mg of first-class Sargol saffron (preparation of tablets will be done at the Faculty of Pharmacy). Interventi

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Patients who are willing to participate in the study Migraine Migraine diagnosis by a neurologist based on the International Classification of Headache Disorders-3 (ICHD-3) Age 20 to 50 years At least one year has passed since the migraine diagnosis

Exclusion criteria

Exclusion criteria: Patients with a history of saffron allergy Suffering from cardiovascular diseases, diabetes, liver and kidney diseases, malignancies and other neurological disorders Pregnancy and lactation Taking anticoagulants Adherence to a specific diet in the last 3 months Smoking

Design outcomes

Primary

MeasureTime frame
Severity of migraine attacks. Timepoint: At baseline and after 8 weeks. Method of measurement: Visual Analogue Scale (VAS).;Migraine frequency. Timepoint: At baseline and after 8 weeks. Method of measurement: Question / Number of attacks per month.;Duration of migraine headache. Timepoint: At baseline and after 8 weeks. Method of measurement: Question/ average duration of migraine attacks per headache (hours).;Serum levels of C-reactive protein (CRP). Timepoint: At baseline and after 8 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits.;Serum level of superoxide dismutase (SOD). Timepoint: At baseline and after 8 weeks. Method of measurement: Kiazist biochemical kit.;Serum level of malondialdehyde (MDA). Timepoint: At baseline and after 8 weeks. Method of measurement: Kiazist biochemical kit.;Total antioxidant capacity. Timepoint: At baseline and after 8 weeks. Method of measurement: Kiazist biochemical kit.;Serum level of Nitric Oxide. Timepoint: At baseline and after 8 weeks. Method of measurement: Kiazist biochemical kit.

Secondary

MeasureTime frame
Mental health (Stress, anxiety, depression). Timepoint: At baseline and after 8 weeks. Method of measurement: Depression, Anxiety and Stress Scale-21 questionnaire (DASS-21).;Quality of Life of Migraine Patients. Timepoint: At baseline and after 8 weeks. Method of measurement: Migraine –Specific Quality of Life (MSQ) questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Gholamreza Askari

Esfahan University of Medical Sciences

askari@mui.ac.ir+98 31 3792 3060

Outcome results

None listed

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