Diabetic Peripheral Neuropathy Clinical Trial
Official title:
The Safety and Efficacy of Neuragen in Diabetic Peripheral Neuropathy: A Double-blind Randomized Placebo Controlled Trial
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Status | Withdrawn |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 |
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 |
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.
Status | Withdrawn |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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Pain Management Unit | Halifax | Nova Scotia |
Canada | Robert Schad Naturopathic Clinic | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
The Canadian College of Naturopathic Medicine | Queen Elizabeth II Health Sciences Centre |
Canada,
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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