Neuropathic PainGeranium OilNCT01007747
EPT 100: Geranium Oil for the Relief of Neuropathic Pain
A study testing Geranium oil in people with Neuropathic Pain, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if Geranium oil will relieve a variety of neuropathic pain and some pain relief will last more than 48 hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Geranium oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or oler
- Neuralgia or neuropathy with daily pain
- At least moderate intensity pain
- Signed informed consent
Who cannot join
- Pregnant or nursing
- Known allergies to geranium oil or geranium oil fractions
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
The purpose of this study is to determine if Geranium oil will relieve a variety of neuropathic pain and some pain relief will last more than 48 hours.
Read the detailed description
EPT 100 study is designed to identify the percentage of people who experience neuropathic pain relief from topical geranium oil from Reunion Island, determine which neuropathic pain conditions respond best and define the time course of the pain relief.
- Conditions
- Neuropathic Pain
- Being tested
- Geranium oil
- Keywords
- Geranium oil, Neuropathy
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geranium oilOther
Daily topical application over neuropathic pain
| Study group | Role | What they receive |
|---|---|---|
| Geranium oil | Experimental | Not described Receives: Other: Geranium oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Measured: 3 times in 30 to 60 minutes post-application
Secondary outcomes (1)
Response to therapy at 30 to 60 minutes, they will be asked to apply the oil to painful area daily
Measured: Daily over 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startNov 2008
- Primary completionJun 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Greenway, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007747
- Sponsor's protocol ID
- PBRC 21033
- Acronym
- Geranium Oil
- Status last verified
- Dec 2015
- First submitted
- 3 Nov 2009
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPT 100: Geranium Oil for the Relief of Neuropathic Pain
- ClinicalTrials.gov ID
- NCT01007747
- Acronym / sponsor ID
- Geranium Oil / PBRC 21033
- Conditions
- Neuropathic Pain
- Keywords
- Geranium oil, Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 4 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if Geranium oil will relieve a variety of neuropathic pain and some pain relief will last more than 48 hours.
Detailed description
EPT 100 study is designed to identify the percentage of people who experience neuropathic pain relief from topical geranium oil from Reunion Island, determine which neuropathic pain conditions respond best and define the time course of the pain relief.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geranium oil | Experimental | Other: Geranium oil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or oler
- Neuralgia or neuropathy with daily pain
- At least moderate intensity pain
- Signed informed consent
Key exclusion criteria (2 listed)
- Pregnant or nursing
- Known allergies to geranium oil or geranium oil fractions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geranium oilDaily topical application over neuropathic pain | Other | Geranium oil |
Primary outcome
Pain relief
Time frame: 3 times in 30 to 60 minutes post-application
1 secondary outcome
Response to therapy at 30 to 60 minutes, they will be asked to apply the oil to painful area daily
Time frame: Daily over 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
Related trials for Neuropathic Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geranium oil in people with Neuropathic Pain, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: 3 times in 30 to 60 minutes post-application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2015.