Neuragen for Peripheral Diabetic Neuropathy

Phase 3

Withdrawn

• Conditions: Diabetic Peripheral Neuropathy; Diabetic Neuralgia
• Interventions: Other: Mineral oil; Other: Neuragen

• Registration Number: NCT00861952
• Lead Sponsor: The Canadian College of Naturopathic Medicine

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.

Study Timeline

• Study First Submitted: 2009-03-13
• Study First Submitted QC: 2009-03-13
• Study First Posted: 2009-03-16
• Study Start: 2010-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mineral oil	Mineral oil	Mineral oil, scent and color matched to intervention
Neuragen	Neuragen	Ad lib use of Neuragen (a natural health product) applied topically 2-3 times per day in 2-3 drops per application

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adverse event reports	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
NeuroQol-97 quality of life measurement questionnaire	Baseline to 3 months
Amount of medication used	Baseline to 3 months

Trial Locations

Locations (2)

Robert Schad Naturopathic Clinic; 🇨🇦 Toronto, Ontario, Canada

Pain Management Unit; 🇨🇦 Halifax, Nova Scotia, Canada