The effects of phytosomal curcumin supplementation on clinical symptoms, and inflammatory and oxidative stress biomarkers in patients with migraine: A protocol for a randomized double-blind placebo-controlled trial

OBJECTIVE: Migraine is one of the most common diseases. Curcumin with anti-oxidative and anti-neuroinflammatory properties might have beneficial effects in migraine patients. This study will be conducted to evaluate the effects of a phytosomal preparation of curcumin on clinical signs, oxidative stress, and inflammatory parameters in patients with migraine. MATERIALS AND METHODS: This is a randomized, double-blind, placebo-controlled, clinical trial in which, 60 patients with migraine will be assigned to receive a daily dose of 250 mg of phytosomal curcumin for 8 weeks (intervention group) or 250 mg maltodextrin as a placebo for the same duration (control group). Before and after the study, frequency, duration, and severity of the attacks, quality of life and sleep, mood status, high-sensitivity C-reactive protein (hs-CRP), Nitric Oxide (NO), and oxidative stress factors will be measured. CONCLUSION: It seems that phytosomal formulation of curcumin (a solid dispersion preparation of curcumin with phosphatidylserine) with high bioavailability, can cross the blood-brain barrier (BBB) and result in decreased neuroinflammation, oxidative stress, and neurotoxicity. This way, phytosomal curcumin might lead to reduction of headaches and other complications of migraine and increase the quality of life of patients with migraine.