NCT00861952

Brief Summary

The purpose of this study is to determine if the use of Neuragen (a natural health product oil rubbed into the skin) is effective at reducing pain and improving the quality of life in people with diabetic peripheral neuropathy.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

First Submitted

Initial submission to the registry

March 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 16, 2009

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

First QC Date

March 13, 2009

Last Update Submit

March 10, 2015

Conditions

Diabetic Peripheral NeuropathyDiabetic Neuralgia

Keywords

Diabetic peripheral neuropathiesNeuralgiaComplementary medicineAnalgesia

Outcome Measures

Primary Outcomes (2)

  • Brief Pain Inventory for sustained relief

    Baseline to month 3

  • Numeric pain scale (0-10) for immediate relief

    Baseline compared to average daily measure over 3 months

Secondary Outcomes (7)

  • NeuroQol-97 quality of life measurement questionnaire

    Baseline to 3 months

  • Liver enzyme - AST

    Baseline to 3 months

  • Liver enzyme - ALT

    Baseline to 3 months

  • Liver enzyme - GGT

    Baseline to 3 months

  • Neurologic impairment scale LL +7

    Baseline to 3 months

  • +2 more secondary outcomes

Study Arms (2)

Neuragen

EXPERIMENTAL

Ad lib use of Neuragen (a natural health product) applied topically 2-3 times per day in 2-3 drops per application

Other: Neuragen

Mineral oil

SHAM COMPARATOR

Mineral oil, scent and color matched to intervention

Other: Mineral oil

Interventions

NeuragenOTHER

2-3 drops applied topically 2-3 times per day as needed over a 3 month period

Neuragen
Mineral oilOTHER

Ad lib use of mineral (scent and color matched to Neuragen) applied topically 2-3 times per day in 2-3 drops per application

Mineral oil

Eligibility Criteria

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

You may qualify if:

  • Men and women of at least 18 years of age
  • Established diagnosis of neuropathic pain for at least the past 3 months duration, and type 1 or type 2 diabetes, confirmed by primary care physician and/or neurologist. By signing the informed consent, participants agree to have the study coordinator contact their physician for confirmation of diagnosis.
  • Pain of at least level 4 on a 0-10 scale, and not over 9, despite other treatments on intake.
  • Presence of dynamic tactile allodynia or pinprick hyperalgesia
  • Normal cognitive and communication skills (as judged by investigator) and ability to complete self-report questionnaires.

You may not qualify if:

  • Pregnancy
  • Previous or continuing use of Neuragen®
  • Evidence of other types of pain as, or more severe, than the pain under study
  • Major psychological conditions requiring treatment
  • History of eczema/atopy/anaphylaxis or unusual skin reactions. This will be assessed using a subjective question (Have you ever suffered from eczema? Or experienced a skin reaction to a substance? Or experienced an anaphylactic reaction?)
  • Self reported sensitivity to perfumes, essential oils, odors.
  • Changes to current pain management regime within the previous month prior to start of study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pain Management Unit

Halifax, Nova Scotia, B3H1V7, Canada

Location

Robert Schad Naturopathic Clinic

Toronto, Ontario, M2K 1E2, Canada

Location

MeSH Terms

Conditions

Diabetic NeuropathiesNeuralgiaAgnosia

Interventions

Mineral Oil

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

PetrolatumHydrocarbonsOrganic Chemicals

Study Officials

  • Mary Lynch, MD

    Dalhousie University

    STUDY CHAIR

  • Kieran Cooley, ND

    The Canadian College of Naturopathic Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director, Research

Study Record Dates

First Submitted

March 13, 2009

First Posted

March 16, 2009

Study Start

January 1, 2010

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

CA(2)