Efficacy of combination of Viola odorata, Rosa damascena and Coriandrum sativum in prevention of migraine attacks: a randomized, double blind, placebo-controlled clinical trial.

Background: Migraine is the second most common type of headache after tension headaches. In Iranian traditional medicine several herbal drugs are used for the treatment of headache. Including, a product of Iranian traditional medicine, a combination of Viola odorata L. flowers, Rosa damascena L. flowers and Coriandrum sativum L. fruits.

Objective: To determine the effectiveness of a combination of Viola odorata flowers, Rosa damascene flowers and Coriandrum sativum fruits on severity, duration and frequency of migraine headaches.

Methods: This randomized, double blind, placebo-controlled clinical trial was performed on 88 patients who had migraine and visited Besat Neurology Clinic No. 4 at Kerman University of Medical Sciences, Kerman, Iran, from September 2016 to march 2017. Patients were randomly divided into the intervention (n=44) or placebo group (n=44). The intervention group received a product of Iranian traditional medicine, a combination of Viola odorata L. flowers, Rosa damascena L. flowers and Coriandrum sativum L. fruits in 500 mg capsules three times a day and propranolol 20mg tablet twice a day, and the control group received placebo capsules (500mg) three times a day and propranolol 20mg tablet twice a day for four weeks. Patients were asked to report the frequency, duration and severity of their headaches in designed forms at home. Then at the end of the 2nd and 4th weeks of treatment, patients were followed for clinical efficacy.

Results: In terms of duration, frequency and severity of headaches between the two groups of herbal medicine and placebo, the behavior of the two protocols was changed over time (p<0.001). During the 4 weeks, the time and drug interactions, were significant (p <0.001). In other words, the pattern of changes to the two protocols over time, was different. Also, at the end of the 4th week, there was a significant difference between the two groups (p<0.001).

Conclusion: The study findings suggest that the Iranian traditional product combination of Viola odorata flowers, Rosa damascena flowers and Coriandrum sativum fruits may be effective in improving headaches in patients with migraine.

Clinical trial registration: The trial was registered at the Iranian registry of clinical trials (IRCT: www.irct.ir) with registered NO. IRCT 2016110830776N1.

Funding: The authors received no financial support for the research, authorship, and/or publication of this article.