- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01022437
Geranium Oil and Its Components for the Relief of Numbness-OB 100
December 17, 2015 updated by: Frank Greenway, Pennington Biomedical Research Center
This study is designed to evaluate the effectiveness of geranium oil and its components in the relief of numbness and the restoration of sensations.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a pilot study to define the time course, the incidence of sensation restoration and the improvement in nerve conduction in people with numbness by using topical geranium oil.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70809
- Penningto Biomedical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age or older
- Neuropathy with the inability to feel touch in a standard nylon filament test
- Signed informed consent
Exclusion Criteria:
- Pregnant or nursing
- Known allergies to geranium oil or geranium oil fractions
- Open sore in the area of numbness
- Migraine headaches or headaches to strong smells
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Geranium Oil and component PN-34
|
Geranium oil as a topical application to the body that is numb, time to determine how long it takes for the feeling to return, if it does so, and if the return of feeling is maintained by daily topical application of oil over 12 weeks.
This including the process of absorption, distribution and localization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response to numbness relief and restoration of sensation
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alok Gupta, MD, Pennington Biomedical Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
November 25, 2009
First Submitted That Met QC Criteria
November 30, 2009
First Posted (Estimate)
December 1, 2009
Study Record Updates
Last Update Posted (Estimate)
December 18, 2015
Last Update Submitted That Met QC Criteria
December 17, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 28041
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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