Clinical trial NCT00861952: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Diabetic Peripheral Neuropathy
Diabetic Neuralgia
Keywords: Diabetic peripheral neuropathies
Neuralgia
Complementary medicine
Analgesia
Lead sponsor: The Canadian College of Naturopathic Medicine
Sponsor class: OTHER
Collaborators: name: Queen Elizabeth II Health Sciences Centre
First posted: 2009-03-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Brief Pain Inventory for sustained relief
timeFrame: Baseline to month 3
measure: Numeric pain scale (0-10) for immediate relief
timeFrame: Baseline compared to average daily measure over 3 months
Secondary outcomes:
measure: NeuroQol-97 quality of life measurement questionnaire
timeFrame: Baseline to 3 months
measure: Liver enzyme - AST
timeFrame: Baseline to 3 months
measure: Liver enzyme - ALT
timeFrame: Baseline to 3 months
measure: Liver enzyme - GGT
timeFrame: Baseline to 3 months
measure: Neurologic impairment scale LL +7
timeFrame: Baseline to 3 months
measure: Amount of medication used
timeFrame: Baseline to 3 months
measure: Adverse event reports
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Pain Management Unit
state: Nova Scotia
city: Toronto
country: Canada
facility: Robert Schad Naturopathic Clinic
state: Ontario
Study officials:
affiliation: Dalhousie University
name: Mary Lynch, MD
role: STUDY_CHAIR
affiliation: The Canadian College of Naturopathic Medicine
name: Kieran Cooley, ND
role: PRINCIPAL_INVESTIGATOR
References: