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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00861952
Other study ID # CCNM-0901
Secondary ID
Status Withdrawn
Phase Phase 3
First received March 13, 2009
Last updated March 10, 2015
Start date January 2010

Study information

Verified date March 2015
Source The Canadian College of Naturopathic Medicine
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Pain Management Unit Halifax Nova Scotia
Canada Robert Schad Naturopathic Clinic Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
The Canadian College of Naturopathic Medicine Queen Elizabeth II Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brief Pain Inventory for sustained relief Baseline to month 3 No
Primary Numeric pain scale (0-10) for immediate relief Baseline compared to average daily measure over 3 months No
Secondary NeuroQol-97 quality of life measurement questionnaire Baseline to 3 months No
Secondary Liver enzyme - AST Baseline to 3 months Yes
Secondary Liver enzyme - ALT Baseline to 3 months Yes
Secondary Liver enzyme - GGT Baseline to 3 months Yes
Secondary Neurologic impairment scale LL +7 Baseline to 3 months No
Secondary Amount of medication used Baseline to 3 months No
Secondary Adverse event reports Baseline to 3 months Yes
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