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

Electron Physician. 2018 Mar 25;10(3):6430-6438. doi: 10.19082/6430. eCollection 2018 Mar. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5942562/ . Kamali M1,2, Seifadini R3, Kamali H3, Mehrabani M4, Jahani Y5,6, Tajadini H2,7. Author information 1 MD, Persian Medicine Student, Neurology Research Center, Kerman University of Medical Sciences, Kerman, Iran. 2 Department of Persian Medicine, School of Persian Medicine, Kerman University of Medical Sciences, Kerman, Iran. 3 MD, Neurologist, Assistant Professor, Neurology Research Center, Kerman University of Medical Sciences, Kerman, Iran. 4 Pharmacognosist, Professor, Department of Pharmacognosy, Herbal and Traditional Medicines Research Center, Kerman University of Medical Sciences, Kerman, Iran. 5 PhD of Biostatistics, Assistant Professor, Modeling in Health Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran. 6 Department of Biostatistics and Epidemiology, School of Public Health, Kerman University of Medical Sciences, Kerman, Iran. 7 MD, PhD of Persian Medicine, Assistant Professor, Neurology Research Center, Kerman University of Medical Sciences, Kerman, Iran. Abstract 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. KEYWORDS: Coriandrum; Headache; Migraine; Traditional medicine; Viola PMID: 29765566 PMCID: PMC5942562 DOI: 10.19082/6430 Free PMC Article