Lippia Alba for Migraine Prophylaxis and Treatment

NCT ID: NCT01259947

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2010-10-31

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

Conditions

Migraine Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lippia alba

Group Type: EXPERIMENTAL

Lippia alba (Mill.) N. E. Brown ethanolic extract

Intervention Type: DRUG

1-2 drops per kilogram per day, PO, twice a day

Interventions

Lippia alba (Mill.) N. E. Brown ethanolic extract

1-2 drops per kilogram per day, PO, twice a day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Migraine diagnostic

Exclusion Criteria

• Patient's request

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fabio Carmona

OTHER

Sponsor Role: lead

Responsible Party

Fabio Carmona

Technical coordinator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Raul Conde, MD

Role: PRINCIPAL_INVESTIGATOR

Reserva EcoCerrado Brasil

Ana MS Pereira, PhD

Role: STUDY_CHAIR

Casa Espirita Terra de Ismael

Locations

Naturoterapia Sinho Mariano

Araxá, Minas Gerais, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 23639189 (View on PubMed)

Conde R, Correa 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.

Reference Type: DERIVED

PMID: 21802924 (View on PubMed)

Other Identifiers

LALBA201012

Identifier Type: -

Identifier Source: org_study_id