- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01007747
EPT 100: Geranium Oil for the Relief of Neuropathic Pain (Geranium Oil)
December 17, 2015 updated by: Frank Greenway, Pennington Biomedical Research Center
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
166
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Geranium oil
|
Daily topical application over neuropathic pain
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pain relief
Time Frame: 3 times in 30 to 60 minutes post-application
|
3 times in 30 to 60 minutes post-application
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Daily over 1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
November 3, 2009
First Submitted That Met QC Criteria
November 3, 2009
First Posted (Estimate)
November 4, 2009
Study Record Updates
Last Update Posted (Estimate)
December 18, 2015
Last Update Submitted That Met QC Criteria
December 17, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 21033
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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