Neuragen for Peripheral Diabetic Neuropathy

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

The Safety and Efficacy of Neuragen in Diabetic Peripheral Neuropathy: A Double-blind Randomized Placebo Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00861952
• Other study ID #: CCNM-0901
• Status: Withdrawn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• Status: Withdrawn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
• 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

• Diabetic Neuralgia
• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Neuralgia
• Peripheral Nervous System Diseases

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