The purpose of this study is to determine which component of an artificial geranium oil
helps to reduce your neuropathy pain.
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.
- You are eligible to participate in this study if you have completed the study EPT 100
and geranium oil relieves your neuropathy pain successfully.
- 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