Comparison of 2 Vials of Components of a Synthetic 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, Shingles, Herpes zoster
Eligibility Criteria
Inclusion Criteria:
- You are eligible to participate in this study if you have completed the study EPT 100 and geranium oil relieves your neuropathy pain successfully.
Exclusion Criteria:
- You are ineligible to participate in this study if you have completed the study EPT 100 and geranium oil does not relieve your neuropathy pain successfully
Sites / Locations
- Pennington Biomedical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1 Geranium Oil
2 Geramium Oil
Arm Description
Outcomes
Primary Outcome Measures
Pain relief
Secondary Outcome Measures
Response to therapy at one hour, defined as reduction of pain summed over the first hour, compared between the two oils.
Full Information
NCT ID
NCT00611949
First Posted
January 29, 2008
Last Updated
December 17, 2015
Sponsor
Pennington Biomedical Research Center
1. Study Identification
Unique Protocol Identification Number
NCT00611949
Brief Title
Comparison of 2 Vials of Components of a Synthetic Geranium Oil
Official Title
EPT 101: New Geranium Oil Formulation for the Treatment of Neuropathy Pain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 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 which component of an artificial geranium oil helps to reduce your neuropathy pain.
Detailed Description
EPT 101 is a double-blind successive crossover study designed to determine which components of a synthetic geranium oil provide analgesic relief, with the objective of identifying and purifying the active substance. This is not a hypothesis-generating trial, nor is it confirming a hypothesis. The trial uses human volunteers in an efficacy-directed decomposition of a complex mixture.
Patients with a diagnosis of neuralgia or neuropathy who respond to geranium oil will test two vials of components of a synthetic geranium oil for application to the maximally painful area in succession. They will treat their condition in the clinic and fill out a patient diary on separate days. The primary objective is the patient opinion of which vial has greatest analgesic efficacy. Efficacy will be measured primarily by reduction in pain intensity summed over the first two hours, compared with the pain intensity during the 30 minutes preceding application.
Following the comparison of the first two vials, the vial judged efficacious will be decomposed into two further vials and the patients will repeat the evaluation described above. At least eight pair-wise comparisons will be required to determine and confirm which of the 100+ ingredients of a synthetic geranium oil are analgesic, provided there is only one such ingredient.
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, Shingles, Herpes zoster
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Geranium Oil
Arm Type
Active Comparator
Arm Title
2 Geramium Oil
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Geranium oil
Intervention Description
2 applications of topical oil per week for 2 weeks
Primary Outcome Measure Information:
Title
Pain relief
Time Frame
2 hrs. post-application
Secondary Outcome Measure Information:
Title
Response to therapy at one hour, defined as reduction of pain summed over the first hour, compared between the two oils.
Time Frame
1 hr. post-application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
You are eligible to participate in this study if you have completed the study EPT 100 and geranium oil relieves your neuropathy pain successfully.
Exclusion Criteria:
You are ineligible to participate in this study if you have completed the study EPT 100 and geranium oil does not relieve your neuropathy pain successfully
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Greenway, MD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
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
Comparison of 2 Vials of Components of a Synthetic Geranium Oil
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