Lippia Alba for Migraine Prophylaxis and Treatment

NCT01259947 | Completed Phase 2 DMC

• 1 other identifier: LALBA201012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

headache; migraine; medicinal plant; essential oil; phytotherapy

Study Arms (1)

Lippia alba

EXPERIMENTAL

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

Interventions

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

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

Lippia alba

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Migraine diagnostic

You may not qualify if:

• Patient's request

Sponsors & Collaborators

• Fabio Carmona: lead

Study Sites (1)

Naturoterapia Sinho Mariano

Araxá, Minas Gerais, Brazil

Location

Related Publications (2)

• 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.

  PMID: 23639189 DERIVED

• 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.

  PMID: 21802924 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Raul Conde, MD

  Reserva EcoCerrado Brasil

  PRINCIPAL INVESTIGATOR

• Ana MS Pereira, PhD

  Casa Espirita Terra de Ismael

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Technical coordinator

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: December 15, 2010
• Study Start: July 1, 2006
• Primary Completion: April 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 27, 2016

Record last verified: 2016-01

Locations

BR (1)