NCT01022437

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

2.8 years

First QC Date

November 25, 2009

Last Update Submit

December 17, 2015

Conditions

Nerve ConductionNumbness

Outcome Measures

Primary Outcomes (1)

  • Response to numbness relief and restoration of sensation

    12 weeks

Study Arms (1)

Geranium Oil and component PN-34

EXPERIMENTAL
Other: Geranium Oil with component PN-34

Interventions

Geranium Oil with component PN-34OTHER

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.

Geranium Oil and component PN-34

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Neuropathy with the inability to feel touch in a standard nylon filament test
  • Signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penningto Biomedical Research Center

Baton Rouge, Louisiana, 70809, United States

Location

MeSH Terms

Conditions

Hypesthesia

Condition Hierarchy (Ancestors)

Somatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alok Gupta, MD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Medical Doctor

Study Record Dates

First Submitted

November 25, 2009

First Posted

December 1, 2009

Study Start

December 1, 2008

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

December 18, 2015

Record last verified: 2015-12

Locations

US(1)