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Neuragen for Peripheral Diabetic Neuropathy

Primary Purpose

Diabetic Peripheral Neuropathy, Diabetic Neuralgia

Status
Withdrawn
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Neuragen
Mineral oil
Sponsored by
The Canadian College of Naturopathic Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathy focused on measuring Diabetic peripheral neuropathies, Neuralgia, Complementary medicine, Analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pain Management Unit
  • Robert Schad Naturopathic Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Neuragen

Mineral oil

Arm Description

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

Mineral oil, scent and color matched to intervention

Outcomes

Primary Outcome Measures

Brief Pain Inventory for sustained relief
Numeric pain scale (0-10) for immediate relief

Secondary Outcome Measures

NeuroQol-97 quality of life measurement questionnaire
Liver enzyme - AST
Liver enzyme - ALT
Liver enzyme - GGT
Neurologic impairment scale LL +7
Amount of medication used
Adverse event reports

Full Information

First Posted
March 13, 2009
Last Updated
March 10, 2015
Sponsor
The Canadian College of Naturopathic Medicine
Collaborators
Queen Elizabeth II Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00861952
Brief Title
Neuragen for Peripheral Diabetic Neuropathy
Official Title
The Safety and Efficacy of Neuragen in Diabetic Peripheral Neuropathy: A Double-blind Randomized Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Study has received ethics approval, however funding limitations have resulted in suspending date of commencement.
Study Start Date
January 2010 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Canadian College of Naturopathic Medicine
Collaborators
Queen Elizabeth II Health Sciences Centre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy, Diabetic Neuralgia
Keywords
Diabetic peripheral neuropathies, Neuralgia, Complementary medicine, Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuragen
Arm Type
Experimental
Arm Description
Ad lib use of Neuragen (a natural health product) applied topically 2-3 times per day in 2-3 drops per application
Arm Title
Mineral oil
Arm Type
Sham Comparator
Arm Description
Mineral oil, scent and color matched to intervention
Intervention Type
Other
Intervention Name(s)
Neuragen
Intervention Description
2-3 drops applied topically 2-3 times per day as needed over a 3 month period
Intervention Type
Other
Intervention Name(s)
Mineral oil
Intervention Description
Ad lib use of mineral (scent and color matched to Neuragen) applied topically 2-3 times per day in 2-3 drops per application
Primary Outcome Measure Information:
Title
Brief Pain Inventory for sustained relief
Time Frame
Baseline to month 3
Title
Numeric pain scale (0-10) for immediate relief
Time Frame
Baseline compared to average daily measure over 3 months
Secondary Outcome Measure Information:
Title
NeuroQol-97 quality of life measurement questionnaire
Time Frame
Baseline to 3 months
Title
Liver enzyme - AST
Time Frame
Baseline to 3 months
Title
Liver enzyme - ALT
Time Frame
Baseline to 3 months
Title
Liver enzyme - GGT
Time Frame
Baseline to 3 months
Title
Neurologic impairment scale LL +7
Time Frame
Baseline to 3 months
Title
Amount of medication used
Time Frame
Baseline to 3 months
Title
Adverse event reports
Time Frame
Baseline to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Lynch, MD
Organizational Affiliation
Dalhousie University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kieran Cooley, ND
Organizational Affiliation
The Canadian College of Naturopathic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain Management Unit
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H1V7
Country
Canada
Facility Name
Robert Schad Naturopathic Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2K 1E2
Country
Canada

12. IPD Sharing Statement

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Neuragen for Peripheral Diabetic Neuropathy

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