Clinical Trials Directory

Trials / Completed

CompletedNCT01259947

Lippia Alba for Migraine Prophylaxis and Treatment

Chemical Composition and Therapeutic Effects of Lippia Alba (Mill.) N. E. Brown Leaves Ethanolic Extract in Patients With Migraine

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Fabio Carmona · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

Conditions

Interventions

TypeNameDescription
DRUGLippia alba (Mill.) N. E. Brown ethanolic extract1-2 drops per kilogram per day, PO, twice a day

Timeline

Start date
2006-07-01
Primary completion
2010-04-01
Completion
2010-10-01
First posted
2010-12-15
Last updated
2016-01-27

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT01259947. Inclusion in this directory is not an endorsement.