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

Numbness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022437
• Other study ID #: PBRC 28041
• Status: Completed
• Phase: N/A
• First received: November 25, 2009
• Last updated: December 17, 2015
• Start date: December 2008
• Est. completion date: October 2011

Study information

• Verified date: December 2015
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypesthesia
• Nerve Conduction
• Numbness

Intervention

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.

Locations

Country	Name	City	State
United States	Penningto Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to numbness relief and restoration of sensation		12 weeks	No