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

• Sponsor: Pennington Biomedical Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01022437
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Arm: 1
• Duration (Months): 34
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Nerve Conduction; Numbness	Other: Geranium Oil with component PN-34	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: N/A
• 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: Dec 1, 2008
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Response to numbness relief and restoration of sensation [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penningto Biomedical Research Center	Baton Rouge	Louisiana	United States	70809

Sponsors and Collaborators

• Pennington Biomedical Research Center

Investigators

• Principal Investigator: Alok Gupta, MD, Pennington Biomedical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Frank Greenway, Clinical Medical Doctor, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT01022437
• Other Study ID Numbers: PBRC 28041
• First Posted: Dec 1, 2009
• Last Update Posted: Dec 18, 2015
• Last Verified: Dec 1, 2015

• Additional relevant MeSH terms: Hypesthesia

Study Results

No Results Posted as of Dec 18, 2015