Back to resultsGeranium Oil and Its Components for the Relief of Numbness-OB 100
Primary Purpose
Nerve Conduction, Numbness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Geranium Oil with component PN-34
Sponsored by
About this trial
This is an interventional supportive care trial for Nerve Conduction
Eligibility Criteria
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
Sites / Locations
- Penningto Biomedical Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Geranium Oil and component PN-34
Arm Description
Outcomes
Primary Outcome Measures
Response to numbness relief and restoration of sensation
Secondary Outcome Measures
Full Information
NCT ID
NCT01022437
First Posted
November 25, 2009
Last Updated
December 17, 2015
Sponsor
Pennington Biomedical Research Center
1. Study Identification
Unique Protocol Identification Number
NCT01022437
Brief Title
Geranium Oil and Its Components for the Relief of Numbness-OB 100
Official Title
Geranium Oil and Its Components for the Relief of Numbness-OB 100
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to evaluate the effectiveness of geranium oil and its components in the relief of numbness and the restoration of sensations.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nerve Conduction, Numbness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Geranium Oil and component PN-34
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Geranium Oil with component PN-34
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response to numbness relief and restoration of sensation
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alok Gupta, MD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penningto Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Geranium Oil and Its Components for the Relief of Numbness-OB 100
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