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Geranium Oil and Its Components for the Relief of Numbness-OB 100

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ClinicalTrials.gov Identifier: NCT01022437
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : December 18, 2015
Sponsor:
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center

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.

Condition or disease Intervention/treatment Phase
Nerve Conduction Numbness Other: Geranium Oil with component PN-34 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Geranium Oil and Its Components for the Relief of Numbness-OB 100
Study Start Date : December 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Arm Intervention/treatment
Experimental: Geranium Oil and component PN-34 Other: Geranium Oil with 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.




Primary Outcome Measures :
  1. Response to numbness relief and restoration of sensation [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022437


Locations
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United States, Louisiana
Penningto Biomedical Research Center
Baton Rouge, Louisiana, United States, 70809
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
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Principal Investigator: Alok Gupta, MD Pennington Biomedical Research Center

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Responsible Party: Frank Greenway, Clinical Medical Doctor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01022437     History of Changes
Other Study ID Numbers: PBRC 28041
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
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Hypesthesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms