Geranium Oil and Its Components for the Relief of Numbnes... | NCT01022437

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

NCT01022437

Sponsor

Pennington Biomedical Research Center

Status

Completed

Last Update Posted

Dec 18, 2015Estimated

Enrollment

13Actual

Phase

Not Applicable

Conditions

Nerve Conduction
Numbness

Interventions

Geranium Oil with component PN-34

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Nov 25, 2009

First Submission Date that Met QC Criteria

Nov 30, 2009

First Posted Date

Dec 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2015

Last Update Posted Date

Dec 18, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Frank Greenway, Clinical Medical Doctor, Pennington Biomedical Research CenterPrincipal Investigator

Lead Sponsor

Pennington Biomedical Research CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Geranium Oil and component PN-34	Experimental		Other: Geranium Oil with component PN-34

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Geranium Oil with component PN-34	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response to numbness relief and restoration of sensation		12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alok Gupta, MD	Pennington Biomedical Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Penningto Biomedical Research Center		Baton Rouge	Louisiana	70809	United States

Condition Browse Module

MeSH Terms

ID	Term
D006987	Hypesthesia

Ancestor Terms

ID	Term
D020886	Somatosensory Disorders
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided