Diabetic Peripheral NeuropathyPhase 3NCT00861952
Neuragen for Peripheral Diabetic Neuropathy
A Phase 3 study testing Neuragen and Mineral oil in people with Diabetic Peripheral Neuropathy and Diabetic Neuralgia, run by The Canadian College of Naturopathic Medicine at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathy, Diabetic Neuralgia
- What is being tested?
- Neuragen and Mineral oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2010to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Pain Management Unit
Halifax, Nova Scotia, B3H1V7
Robert Schad Naturopathic Clinic
Toronto, Ontario, M2K 1E2
About this study
Official title: The Safety and Efficacy of Neuragen in Diabetic Peripheral Neuropathy: A Double-blind Randomized Placebo Controlled Trial
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.
Read the 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.
- Conditions
- Diabetic Peripheral Neuropathy, Diabetic Neuralgia
- Being tested
- Neuragen, Mineral oil
- Keywords
- Diabetic peripheral neuropathies, Neuralgia, Complementary medicine, Analgesia
- Medical subject headings
- Diabetic Neuropathies, Neuralgia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuragenOther
2-3 drops applied topically 2-3 times per day as needed over a 3 month period
Mineral oilOther
Ad lib use of mineral (scent and color matched to Neuragen) applied topically 2-3 times per day in 2-3 drops per application
| Study group | Role | What they receive |
|---|---|---|
| Neuragen | Experimental | Ad lib use of Neuragen (a natural health product) applied topically 2-3 times per day in 2-3 drops per application Receives: Other: Neuragen |
| Mineral oil | Sham comparator | Mineral oil, scent and color matched to intervention Receives: Other: Mineral oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory for sustained relief
Measured: Baseline to month 3
Numeric pain scale (0-10) for immediate relief
Measured: Baseline compared to average daily measure over 3 months
Secondary outcomes (7)
NeuroQol-97 quality of life measurement questionnaire
Measured: Baseline to 3 months
Liver enzyme - AST
Measured: Baseline to 3 months
Liver enzyme - ALT
Measured: Baseline to 3 months
Liver enzyme - GGT
Measured: Baseline to 3 months
Neurologic impairment scale LL +7
Measured: Baseline to 3 months
Amount of medication used
Measured: Baseline to 3 months
Adverse event reports
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study startJan 2010
Why it stopped: Study has received ethics approval, however funding limitations have resulted in suspending date of commencement.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Canadian College of Naturopathic Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Elizabeth II Health Sciences Centre
- Responsible party
- Principal investigator, Kieran Cooley, The Canadian College of Naturopathic Medicine
- Investigators
- Mary Lynch, MD, Study chair, Dalhousie UniversityKieran Cooley, ND, Principal investigator, The Canadian College of Naturopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861952
- Sponsor's protocol ID
- CCNM-0901
- Status last verified
- Mar 2015
- First submitted
- 13 Mar 2009
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Neuragen in Diabetic Peripheral Neuropathy: A Double-blind Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00861952
- Acronym / sponsor ID
- CCNM-0901
- Conditions
- Diabetic Peripheral Neuropathy, Diabetic Neuralgia
- Keywords
- Diabetic peripheral neuropathies, Neuralgia, Complementary medicine, Analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study has received ethics approval, however funding limitations have resulted in suspending date of commencement.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Canadian College of Naturopathic MedicineUniversity, hospital or other
- Collaborators
- Queen Elizabeth II Health Sciences Centre
- Study start
- Jan 2010
- First posted
- 16 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuragen | Experimental | Other: NeuragenAd lib use of Neuragen (a natural health product) applied topically 2-3 times per day in 2-3 drops per application |
| Mineral oil | Sham comparator | Other: Mineral oilMineral oil, scent and color matched to intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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?)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuragen2-3 drops applied topically 2-3 times per day as needed over a 3 month period | Other | Neuragen |
| Mineral oilAd lib use of mineral (scent and color matched to Neuragen) applied topically 2-3 times per day in 2-3 drops per application | Other | Mineral oil |
Primary outcome
Brief Pain Inventory for sustained relief
Time frame: Baseline to month 3
Numeric pain scale (0-10) for immediate relief
Time frame: Baseline compared to average daily measure over 3 months
7 secondary outcomes
NeuroQol-97 quality of life measurement questionnaire
Time frame: Baseline to 3 months
Liver enzyme - AST
Time frame: Baseline to 3 months
Liver enzyme - ALT
Time frame: Baseline to 3 months
Liver enzyme - GGT
Time frame: Baseline to 3 months
Neurologic impairment scale LL +7
Time frame: Baseline to 3 months
Amount of medication used
Time frame: Baseline to 3 months
Adverse event reports
Time frame: Baseline to 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Lynch, MD study chair
Dalhousie University
Kieran Cooley, ND principal investigator
The Canadian College of Naturopathic Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neuragen and Mineral oil in people with Diabetic Peripheral Neuropathy and Diabetic Neuralgia, run by The Canadian College of Naturopathic Medicine at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory for sustained relief (time frame: Baseline to month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.