Lippia Alba for Migraine Prophylaxis and Treatment

Migraine Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259947
• Other study ID #: LALBA201012
• Status: Completed
• Phase: Phase 2
• First received: December 14, 2010
• Last updated: January 26, 2016
• Start date: July 2006
• Est. completion date: October 2010

Study information

• Verified date: January 2016
• Source: Casa Espirita Terra de Ismael
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Conselho Nacional de Saude, Comissao Nacional de Etica em Pesquisa
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Migraine diagnostic

Exclusion Criteria:

• Patient's request

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• Lippia alba (Mill.) N. E. Brown ethanolic extract
1-2 drops per kilogram per day, PO, twice a day

Locations

Country	Name	City	State
Brazil	Naturoterapia Sinho Mariano	Araxa	MG

Sponsors (1)

Lead Sponsor	Collaborator
Fabio Carmona

Country where clinical trial is conducted

Brazil,