Neuragen for Peripheral Diabetic Neuropathy

NCT ID: NCT00861952

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31

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.

Conditions

Diabetic Peripheral Neuropathy; Diabetic Neuralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Neuragen

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

Group Type: EXPERIMENTAL

Neuragen

Intervention Type: OTHER

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

Mineral oil

Mineral oil, scent and color matched to intervention

Group Type: SHAM_COMPARATOR

Mineral oil

Intervention Type: OTHER

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

Interventions

Neuragen

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

Intervention Type: 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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen Elizabeth II Health Sciences Centre

OTHER

Sponsor Role: collaborator

The Canadian College of Naturopathic Medicine

OTHER

Sponsor Role: lead

Responsible Party

Kieran Cooley

Associate Director, Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Lynch, MD

Role: STUDY_CHAIR

Dalhousie University

Kieran Cooley, ND

Role: PRINCIPAL_INVESTIGATOR

The Canadian College of Naturopathic Medicine

Locations

Pain Management Unit

Halifax, Nova Scotia, Canada

Robert Schad Naturopathic Clinic

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

CCNM-0901

Identifier Type: -

Identifier Source: org_study_id