Back to resultsEPT 100: Geranium Oil for the Relief of Neuropathic Pain (Geranium Oil)
Primary Purpose
Neuropathic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Geranium oil
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain focused on measuring Geranium oil, Neuropathy
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or oler
- Neuralgia or neuropathy with daily pain
- At least moderate intensity pain
- Signed informed consent
Exclusion Criteria:
- Pregnant or nursing
- Known allergies to geranium oil or geranium oil fractions
Sites / Locations
- Pennington Biomedical Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Geranium oil
Arm Description
Outcomes
Primary Outcome Measures
Pain relief
Secondary Outcome Measures
Response to therapy at 30 to 60 minutes, they will be asked to apply the oil to painful area daily
Full Information
NCT ID
NCT01007747
First Posted
November 3, 2009
Last Updated
December 17, 2015
Sponsor
Pennington Biomedical Research Center
1. Study Identification
Unique Protocol Identification Number
NCT01007747
Brief Title
EPT 100: Geranium Oil for the Relief of Neuropathic Pain
Acronym
Geranium Oil
Official Title
EPT 100: Geranium Oil for the Relief of Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if Geranium oil will relieve a variety of neuropathic pain and some pain relief will last more than 48 hours.
Detailed Description
EPT 100 study is designed to identify the percentage of people who experience neuropathic pain relief from topical geranium oil from Reunion Island, determine which neuropathic pain conditions respond best and define the time course of the pain relief.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Geranium oil, Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Geranium oil
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Geranium oil
Intervention Description
Daily topical application over neuropathic pain
Primary Outcome Measure Information:
Title
Pain relief
Time Frame
3 times in 30 to 60 minutes post-application
Secondary Outcome Measure Information:
Title
Response to therapy at 30 to 60 minutes, they will be asked to apply the oil to painful area daily
Time Frame
Daily over 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or oler
Neuralgia or neuropathy with daily pain
At least moderate intensity pain
Signed informed consent
Exclusion Criteria:
Pregnant or nursing
Known allergies to geranium oil or geranium oil fractions
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
12. IPD Sharing Statement
Learn more about this trial
EPT 100: Geranium Oil for the Relief of Neuropathic Pain
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