Neuropathic Pain
Conditions
Keywords
Geranium oil, Neuropathy, Shingles, Herpes zoster
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.
Interventions
OTHERGeranium oil
2 applications of topical oil per week for 2 weeks
Sponsors
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain relief | 2 hrs. post-application |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed