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Comparison of 2 Vials of Components of a Synthetic Geranium Oil

NCT ID: NCT00611949

Last Updated: 2015-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2011-12-31

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.

Conditions

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Neuropathic Pain

Keywords

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Geranium oil Neuropathy Shingles Herpes zoster

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1 Geranium Oil

Group Type ACTIVE_COMPARATOR

Geranium oil

Intervention Type OTHER

2 applications of topical oil per week for 2 weeks

2 Geramium Oil

Group Type ACTIVE_COMPARATOR

Geranium oil

Intervention Type OTHER

2 applications of topical oil per week for 2 weeks

Interventions

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Geranium oil

2 applications of topical oil per week for 2 weeks

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Frank Greenway

Clinical Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frank Greenway, MD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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EPT 101

Identifier Type: -

Identifier Source: secondary_id

PBRC 21013

Identifier Type: -

Identifier Source: org_study_id