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Lippia Alba for Migraine Prophylaxis and Treatment

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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

Tracking Information
First Submitted Date  ICMJE December 14, 2010
First Posted Date  ICMJE December 15, 2010
Last Update Posted Date January 27, 2016
Study Start Date  ICMJE July 2006
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT01259947 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lippia Alba for Migraine Prophylaxis and Treatment
Official Title  ICMJE Chemical Composition and Therapeutic Effects of Lippia Alba (Mill.) N. E. Brown Leaves Ethanolic Extract in Patients With Migraine
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Migraine Disorders
Intervention  ICMJE Drug: Lippia alba (Mill.) N. E. Brown ethanolic extract
1-2 drops per kilogram per day, PO, twice a day
Study Arms  ICMJE Experimental: Lippia alba
Intervention: Drug: Lippia alba (Mill.) N. E. Brown ethanolic extract
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2016)
60
Original Actual Enrollment  ICMJE
 (submitted: December 14, 2010)
313
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Migraine diagnostic

Exclusion Criteria:

  • Patient's request
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01259947
Other Study ID Numbers  ICMJE LALBA201012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fabio Carmona, Casa Espirita Terra de Ismael
Study Sponsor  ICMJE Fabio Carmona
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raul Conde, MD Reserva EcoCerrado Brasil
Study Chair: Ana MS Pereira, PhD Casa Espirita Terra de Ismael
PRS Account Casa Espirita Terra de Ismael
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP