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Lippia Alba for Migraine Prophylaxis and Treatment

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ClinicalTrials.gov Identifier: NCT01259947
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
Fabio Carmona, Casa Espirita Terra de Ismael

Study Description
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Brief 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


Condition or disease Intervention/treatment Phase
Migraine Disorders Drug: Lippia alba (Mill.) N. E. Brown ethanolic extract Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2006
Actual Primary Completion Date : April 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lippia alba Drug: Lippia alba (Mill.) N. E. Brown ethanolic extract
1-2 drops per kilogram per day, PO, twice a day


Outcome Measures
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Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Migraine diagnostic

Exclusion Criteria:

  • Patient's request
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259947


Locations
Brazil
Naturoterapia Sinho Mariano
Araxa, MG, Brazil
Sponsors and Collaborators
Fabio Carmona
Investigators
Principal Investigator: Raul Conde, MD Reserva EcoCerrado Brasil
Study Chair: Ana MS Pereira, PhD Casa Espirita Terra de Ismael
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 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