Status:
WITHDRAWN
Neuragen for Peripheral Diabetic Neuropathy
Lead Sponsor:
The Canadian College of Naturopathic Medicine
Collaborating Sponsors:
Queen Elizabeth II Health Sciences Centre
Conditions:
Diabetic Peripheral Neuropathy
Diabetic Neuralgia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 diab...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00861952
Start Date
January 1 2010
Last Update
March 17 2015
Active Locations (2)
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1
Pain Management Unit
Halifax, Nova Scotia, Canada, B3H1V7
2
Robert Schad Naturopathic Clinic
Toronto, Ontario, Canada, M2K 1E2