Comparison of 2 Vials of Components of a Synthetic Geranium Oil

Study Overview
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Brief Summary
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The purpose of this study is to determine which component of an artificial geranium oil helps to reduce your neuropathy pain.

Detailed Description
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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.

Official Title
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EPT 101: New Geranium Oil Formulation for the Treatment of Neuropathy Pain

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Other: Geranium oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 Geranium Oil<br> | Other: Geranium oil<br>* 2 applications of topical oil per week for 2 weeks<br>|
| Active Comparator: 2 Geramium Oil<br> | Other: Geranium oil<br>* 2 applications of topical oil per week for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief |  | 2 hrs. post-application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to therapy at one hour, defined as reduction of pain summed over the first hour, compared between the two oils. |  | 1 hr. post-application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Geranium oil, Neuropathy, Shingles, Herpes zoster