Lippia Alba for Migraine Prophylaxis and Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

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

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

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	N/A
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 Genetics related topics: Migraine

MedlinePlus related topics: Migraine

U.S. FDA Resources

Arms and Interventions

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

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

Criteria

Inclusion Criteria:

Migraine diagnostic

Exclusion Criteria:

Patient's request

Contacts and Locations

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

Layout table for location information

Brazil
Naturoterapia Sinho Mariano
Araxa, MG, Brazil

Sponsors and Collaborators

Fabio Carmona

Investigators

Layout table for investigator information

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):

Carmona F, Angelucci MA, Sales DS, Chiaratti TM, Honorato FB, Bianchi RV, Pereira AM. Lippia alba (Mill.) N. E. Brown hydroethanolic extract of the leaves is effective in the treatment of migraine in women. Phytomedicine. 2013 Jul 15;20(10):947-50. doi: 10.1016/j.phymed.2013.03.017. Epub 2013 Apr 30.

Conde R, Corrêa VS, Carmona F, Contini SH, Pereira AM. Chemical composition and therapeutic effects of Lippia alba (Mill.) N. E. Brown leaves hydro-alcoholic extract in patients with migraine. Phytomedicine. 2011 Nov 15;18(14):1197-201. doi: 10.1016/j.phymed.2011.06.016. Epub 2011 Jul 29.

Layout table for additonal information

Responsible Party:	Fabio Carmona, Technical coordinator, Casa Espirita Terra de Ismael
ClinicalTrials.gov Identifier:	NCT01259947
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:

Layout table for MeSH terms

Migraine Disorders Headache Disorders, Primary Headache Disorders	Brain Diseases Central Nervous System Diseases Nervous System Diseases

To Top