Neuragen for Peripheral Diabetic Neuropathy

March 10, 2015 updated by: Kieran Cooley, The Canadian College of Naturopathic Medicine

The Safety and Efficacy of Neuragen in Diabetic Peripheral Neuropathy: A Double-blind Randomized Placebo Controlled Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Incidence of diabetic neuropathy and development of diabetic ulcers varies based on the severity (lack of blood sugar control) and duration of diabetes. Estimates of rates of occurrence vary although one prospective study showed 7.2% of newly diagnosed ulcer-free diabetics developed ulcers within one year of being diagnosed. Current treatment initiatives aimed at educating diabetic patients on how to prevent diabetic ulcers and mange peripheral neuropathy have had varied success. Chronic pain is the number one reason that this population seeks help from medical professionals. Diabetics are particularly predisposed to a potentially disabling form of chronic pain known as peripheral neuropathy. In fact, over 50% of diabetics have painful neuropathy, or will develop this condition. Other than the primary goal of addressing blood sugar levels, conventional treatment of diabetic peripheral neuropathy involves prescription gabapentanoids or opiod analgesics, both of which have considerable cost and may be associated with side effects from long-term use and overall limited success rates. Neuragen is an over-the-counter natural health product that may be a safe and effective treatment option for this disease. Using a randomized double-blind placebo control clinical trial the effects of Neuragen on pain, function and quality of life will be assessed.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H1V7
        • Pain Management Unit
    • Ontario
      • Toronto, Ontario, Canada, M2K 1E2
        • Robert Schad Naturopathic Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuragen
Ad lib use of Neuragen (a natural health product) applied topically 2-3 times per day in 2-3 drops per application
Other: Neuragen
2-3 drops applied topically 2-3 times per day as needed over a 3 month period
Sham Comparator: Mineral oil
Mineral oil, scent and color matched to intervention
Other: Mineral oil
Ad lib use of mineral (scent and color matched to Neuragen) applied topically 2-3 times per day in 2-3 drops per application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brief Pain Inventory for sustained relief
Time Frame: Baseline to month 3
Baseline to month 3
Numeric pain scale (0-10) for immediate relief
Time Frame: Baseline compared to average daily measure over 3 months
Baseline compared to average daily measure over 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
NeuroQol-97 quality of life measurement questionnaire
Time Frame: Baseline to 3 months
Baseline to 3 months
Liver enzyme - AST
Time Frame: Baseline to 3 months
Baseline to 3 months
Liver enzyme - ALT
Time Frame: Baseline to 3 months
Baseline to 3 months
Liver enzyme - GGT
Time Frame: Baseline to 3 months
Baseline to 3 months
Neurologic impairment scale LL +7
Time Frame: Baseline to 3 months
Baseline to 3 months
Amount of medication used
Time Frame: Baseline to 3 months
Baseline to 3 months
Adverse event reports
Time Frame: Baseline to 3 months
Baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Canadian College of Naturopathic Medicine

Collaborators

Queen Elizabeth II Health Sciences Centre

Investigators

  • Study Chair: Mary Lynch, MD, Dalhousie University
  • Principal Investigator: Kieran Cooley, ND, The Canadian College of Naturopathic Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Study Registration Dates

First Submitted

March 13, 2009

First Submitted That Met QC Criteria

March 13, 2009

First Posted (Estimate)

March 16, 2009

Study Record Updates

Last Update Posted (Estimate)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCNM-0901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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