Lippia Alba for Migraine Prophylaxis and Treatment
Primary Purpose
Migraine Disorders
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Lippia alba (Mill.) N. E. Brown ethanolic extract
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Disorders focused on measuring headache, migraine, medicinal plant, essential oil, phytotherapy
Eligibility Criteria
Inclusion Criteria:
- Migraine diagnostic
Exclusion Criteria:
- Patient's request
Sites / Locations
- Naturoterapia Sinho Mariano
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lippia alba
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01259947
Brief Title
Lippia Alba for Migraine Prophylaxis and Treatment
Official Title
Chemical Composition and Therapeutic Effects of Lippia Alba (Mill.) N. E. Brown Leaves Ethanolic Extract in Patients With Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fabio Carmona
4. Oversight
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
headache, migraine, medicinal plant, essential oil, phytotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lippia alba
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lippia alba (Mill.) N. E. Brown ethanolic extract
Intervention Description
1-2 drops per kilogram per day, PO, twice a day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Migraine diagnostic
Exclusion Criteria:
Patient's request
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raul Conde, MD
Organizational Affiliation
Reserva EcoCerrado Brasil
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana MS Pereira, PhD
Organizational Affiliation
Casa Espirita Terra de Ismael
Official's Role
Study Chair
Facility Information:
Facility Name
Naturoterapia Sinho Mariano
City
Araxa
State/Province
MG
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
23639189
Citation
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.
Results Reference
derived
PubMed Identifier
21802924
Citation
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.
Results Reference
derived
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Lippia Alba for Migraine Prophylaxis and Treatment
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