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Completed

NCT Number: NCT00611949

Comparison of 2 Vials of Components of a Synthetic Geranium Oil

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

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Key information

Conditions

Neuropathic Pain DNA Virus Infections Herpes Zoster Herpesviridae Infections Infections Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Varicella Zoster Virus Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Geranium oil

Other

2 applications of topical oil per week for 2 weeks

Primary outcomes

  1. Pain relief

    Time frame: 2 hrs. post-application

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2011
Study completion
2011
First posted
Feb 11, 2008
Registry last updated
Dec 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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