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Neuragen for Peripheral Diabetic Neuropathy

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ClinicalTrials.gov Identifier: NCT00861952
Recruitment Status : Withdrawn (Study has received ethics approval, however funding limitations have resulted in suspending date of commencement.)
First Posted : March 16, 2009
Last Update Posted : March 17, 2015
Sponsor:
Collaborator:
Queen Elizabeth II Health Sciences Centre
Information provided by (Responsible Party):
Kieran Cooley, 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.

Condition or disease Intervention/treatment Phase
Diabetic Peripheral Neuropathy Diabetic Neuralgia Other: Neuragen Other: Mineral oil Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Neuragen in Diabetic Peripheral Neuropathy: A Double-blind Randomized Placebo Controlled Trial
Study Start Date : January 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neuragen
Ad lib use of Neuragen (a natural health product) applied topically 2-3 times per day in 2-3 drops per application
Other: Neuragen
2-3 drops applied topically 2-3 times per day as needed over a 3 month period

Sham Comparator: Mineral oil
Mineral oil, scent and color matched to intervention
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




Primary Outcome Measures :
  1. Brief Pain Inventory for sustained relief [ Time Frame: Baseline to month 3 ]
  2. Numeric pain scale (0-10) for immediate relief [ Time Frame: Baseline compared to average daily measure over 3 months ]

Secondary Outcome Measures :
  1. NeuroQol-97 quality of life measurement questionnaire [ Time Frame: Baseline to 3 months ]
  2. Liver enzyme - AST [ Time Frame: Baseline to 3 months ]
  3. Liver enzyme - ALT [ Time Frame: Baseline to 3 months ]
  4. Liver enzyme - GGT [ Time Frame: Baseline to 3 months ]
  5. Neurologic impairment scale LL +7 [ Time Frame: Baseline to 3 months ]
  6. Amount of medication used [ Time Frame: Baseline to 3 months ]
  7. Adverse event reports [ Time Frame: Baseline to 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00861952


Locations
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Canada, Nova Scotia
Pain Management Unit
Halifax, Nova Scotia, Canada, B3H1V7
Canada, Ontario
Robert Schad Naturopathic Clinic
Toronto, Ontario, Canada, M2K 1E2
Sponsors and Collaborators
The Canadian College of Naturopathic Medicine
Queen Elizabeth II Health Sciences Centre
Investigators
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Study Chair: Mary Lynch, MD Dalhousie University
Principal Investigator: Kieran Cooley, ND The Canadian College of Naturopathic Medicine

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Responsible Party: Kieran Cooley, Associate Director, Research, The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT00861952     History of Changes
Other Study ID Numbers: CCNM-0901
First Posted: March 16, 2009    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015
Keywords provided by Kieran Cooley, The Canadian College of Naturopathic Medicine:
Diabetic peripheral neuropathies
Neuralgia
Complementary medicine
Analgesia
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuralgia
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Mineral Oil
Emollients
Dermatologic Agents