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Lippia Alba for Migraine Prophylaxis and Treatment

This study has been completed.
Sponsor:
Information provided by:
Casa Espirita Terra de Ismael
ClinicalTrials.gov Identifier:
NCT01259947
First received: December 14, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  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: Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Casa Espirita Terra de Ismael:

Enrollment: 313
Study Start Date: July 2006
Study Completion Date: October 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Migraine diagnostic

Exclusion Criteria:

  • Patient's request
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259947

Locations
Brazil
Naturoterapia Sinho Mariano
Araxa, MG, Brazil
Sponsors and Collaborators
Casa Espirita Terra de Ismael
Investigators
Principal Investigator: Raul Conde, MD Reserva EcoCerrado Brasil
Study Chair: Ana MS Pereira, PhD Casa Espirita Terra de Ismael
  More Information

No publications provided by Casa Espirita Terra de Ismael

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Fabio Carmona, 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: December 14, 2010
Health Authority: Brazil: Conselho Nacional de Saude, Comissao Nacional de Etica em Pesquisa

Keywords provided by 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 May 16, 2013