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Study has received ethics approval, however funding limitations have resulted in suspending date of commencement.
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| Name | Class |
|---|---|
| Queen Elizabeth II Health Sciences Centre | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuragen | Experimental | Ad lib use of Neuragen (a natural health product) applied topically 2-3 times per day in 2-3 drops per application |
|
| Mineral oil | Sham Comparator | Mineral oil, scent and color matched to intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuragen | Other | 2-3 drops applied topically 2-3 times per day as needed over a 3 month period |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory for sustained relief | Baseline to month 3 | |
| Numeric pain scale (0-10) for immediate relief | Baseline compared to average daily measure over 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| NeuroQol-97 quality of life measurement questionnaire | Baseline to 3 months | |
| Liver enzyme - AST | Baseline to 3 months | |
| Liver enzyme - ALT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Lynch, MD | Dalhousie University | Study Chair |
| Kieran Cooley, ND | The Canadian College of Naturopathic Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain Management Unit | Halifax | Nova Scotia | B3H1V7 | Canada | ||
| Robert Schad Naturopathic Clinic |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D009437 | Neuralgia |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| D008899 | Mineral Oil |
| ID | Term |
|---|---|
| D010577 | Petrolatum |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Mineral oil |
| 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 |
|
| Baseline to 3 months |
| Liver enzyme - GGT | Baseline to 3 months |
| Neurologic impairment scale LL +7 | Baseline to 3 months |
| Amount of medication used | Baseline to 3 months |
| Adverse event reports | Baseline to 3 months |
| Toronto |
| Ontario |
| M2K 1E2 |
| Canada |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |