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Lippia Alba for Migraine Prophylaxis and Treatment
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Migraine Disorders | Drug: Lippia alba (Mill.) N. E. Brown ethanolic extract | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Chemical Composition and Therapeutic Effects of Lippia Alba (Mill.) N. E. Brown Leaves Ethanolic Extract in Patients With Migraine |
| Enrollment: | 60 |
| Study Start Date: | July 2006 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lippia alba |
Drug: Lippia alba (Mill.) N. E. Brown ethanolic extract
1-2 drops per kilogram per day, PO, twice a day
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Migraine diagnostic
Exclusion Criteria:
- Patient's request
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01259947
| Brazil | |
| 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 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Fabio Carmona, Technical coordinator, Casa Espirita Terra de Ismael |
| ClinicalTrials.gov Identifier: | NCT01259947 History of Changes |
| Other Study ID Numbers: |
LALBA201012 |
| Study First Received: | December 14, 2010 |
| Last Updated: | January 26, 2016 |
Keywords provided by Fabio Carmona, Casa Espirita Terra de Ismael:
|
headache migraine medicinal plant essential oil phytotherapy |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Disorders, Primary Headache Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on July 24, 2017