Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
nutmeg1234
Study information
Scientific title
Nutmeg extracts for painful diabetic neuropathy: a randomised controlled trial
Acronym
NUTPADIN
Study hypothesis
Can nutmeg extracts reduce pain and/or improve quality of life in patients with painful diabetic neuropathy?
Ethics approval
Ethics Committee of Faculty Medical Sciences, University of the West Indies, Trinidad, approved on the 6th July 2009
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Can be found at http://nutpadin.webs.com/patientinformation.htm
Condition
Painful diabetic neuropathy
Intervention
A random number generating software will be used to generate two equal sets (32 per set) of random numbers ranging from 1 - 64. Consecutive eligible patients will pick one envelope each containing one number ranging from 1 - 64. All envelopes will be sealed without any external marking and will be drawn blindly from an opaque bag. Patients in set one will be assigned to the intervention and patients in the other set will be given placebo.
Before the intervention a washout period of one week for use of any topical medications in the area of PDN (painful diabetic neuropathy) symptoms will be advised. The baseline outcome measure will be determined after the washout period by a blinded assessor. An independent person not involved in the allocation process will be responsible for distribution of the treatments and placebos. He will advise the patient to apply the formulation only to the affected areas for PDN symptoms. Participants will be instructed to apply four sprays, 3 times a day, followed by gentle massage. This will be done for four weeks. The intervention will be a commercially available topical preparation containing: mace oil (2%) and nutmeg oil (14%), methyl salicylate (6%), menthol (6%), coconut oil and alcohol. The placebo will be a topical preparation containing: methyl salicylate (6%), menthol (6%), coconut oil and alcohol.
Both treatments will be in similar containers bearing numbers (1 - 64) linked to the pre-randomised sequence in the envelopes. They will bear no trademarks or descriptions identifying their main ingredients or composition. With the exception of any prior topical medications used in the area of PDN symptoms, participants will be instructed to remain compliant with all other ongoing therapies (e.g., insulin, oral hypoglycaemics, tricyclic antidepressants, etc). Patients will be followed up for a duration of 4 weeks.
Intervention type
Drug
Phase
Phase III
Drug names
Nutmeg extracts
Primary outcome measures
Pain, measured using the Brief Pain Inventory for Diabetic Painful Neuropathy (BPI-DPN) and The Neuropathic Pain Symptom Inventory (NPSI) at baseline and at one, two and four weeks.
Secondary outcome measures
Quality of life, measured using the Brief Pain Inventory for Diabetic Painful Neuropathy (BPI-DPN) at baseline and at one, two and four weeks.
Overall trial start date
01/09/2009
Overall trial end date
30/10/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 21 years and older, either sex
2. Diabetes or impaired glucose tolerance
3. Neuropathic pains score greater than or equal to 4 as determined by the 4-item Neuropathic Pain (DN4) Questionnaire
4. Symptoms limited to the limbs
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
64
Participant exclusion criteria
1. Other confirmed aetiologies of pain in extremities, e.g., soft tissue injuries/infections, tendinitis, spurs
2. Broken skin near pain sites or active skin rash
3. Known salicylate allergy
Recruitment start date
01/09/2009
Recruitment end date
30/10/2009
Locations
Countries of recruitment
Trinidad and Tobago
Trial participating centre
1 Cedar Avenue
Valsayn North
-
Trinidad and Tobago
Sponsor information
Organisation
University of West Indies (Trinidad)
Sponsor details
St Augustine Campus
St Augustine
-
Trinidad and Tobago
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of West Indies (Trinidad) - St Augustine Campus
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary