Lippia Alba for Migraine Prophylaxis and Treatment
|ClinicalTrials.gov Identifier: NCT01259947|
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : January 27, 2016
Abstract Background: There is no universally accepted and effective prophylaxis of migraine headache episodes. Thus the investigators aimed to investigate the effects of Lippia alba (Mill.) N. E. Brown, an herb with many effects on central nervous system, on pain frequency and intensity of migraine patients.
Methods: Patients were enrolled in a prospective, phase 2, non-controlled cohort study to orally receive ethanolic extract of L. alba leaves (1-2 drips/kg/day). Headache intensity and frequency of episodes were recorded before and after 30-60 days of treatment. The investigators also studied the chemical composition of its essential oil by gas chromatography-mass spectrometry.
Results: The investigators described for the first time a particular L. alba chemotype with geranial and carvenone as major compounds. With treatment, both frequency and intensity of pain episodes significantly decreased from baseline to first reassessment date. More than 80% of patients experienced a minimum 50% reduction on pain intensity and frequency. No side effects were reported.
Conclusions: Treatment with a geranial plus carvenone chemotype of L. alba ethanolic extract is a cheap, widely available, highly effective therapy to reduce both the intensity and the frequency of headache episodes of migraine patients with no side effects.
Keywords: headache, migraine, medicinal plant, essential oil, phytotherapy
|Condition or disease||Intervention/treatment||Phase|
|Migraine Disorders||Drug: Lippia alba (Mill.) N. E. Brown ethanolic extract||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Chemical Composition and Therapeutic Effects of Lippia Alba (Mill.) N. E. Brown Leaves Ethanolic Extract in Patients With Migraine|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||October 2010|
|Experimental: Lippia alba||
Drug: Lippia alba (Mill.) N. E. Brown ethanolic extract
1-2 drops per kilogram per day, PO, twice a day
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259947
|Naturoterapia Sinho Mariano|
|Araxa, MG, Brazil|
|Principal Investigator:||Raul Conde, MD||Reserva EcoCerrado Brasil|
|Study Chair:||Ana MS Pereira, PhD||Casa Espirita Terra de Ismael|