ISRCTN ISRCTN83381712
DOI https://doi.org/10.1186/ISRCTN83381712
Secondary identifying numbers nutmeg1234
Submission date
21/07/2009
Registration date
05/08/2009
Last edited
25/08/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Shastri Motilal
Scientific

1 Cedar Avenue
Valsayn North
-
Trinidad and Tobago

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Can be found at http://nutpadin.webs.com/patientinformation.htm
Scientific titleNutmeg extracts for painful diabetic neuropathy: a randomised controlled trial
Study acronymNUTPADIN
Study objectivesCan nutmeg extracts reduce pain and/or improve quality of life in patients with painful diabetic neuropathy?
Ethics approval(s)Ethics Committee of Faculty Medical Sciences, University of the West Indies, Trinidad, approved on the 6th July 2009
Health condition(s) or problem(s) studiedPainful diabetic neuropathy
InterventionA 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Nutmeg extracts
Primary outcome measurePain, 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 measuresQuality of life, measured using the Brief Pain Inventory for Diabetic Painful Neuropathy (BPI-DPN) at baseline and at one, two and four weeks.
Overall study start date01/09/2009
Completion date30/10/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants64
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/09/2009
Date of final enrolment30/10/2009

Locations

Countries of recruitment

  • Trinidad and Tobago

Study participating centre

1 Cedar Avenue
Valsayn North
-
Trinidad and Tobago

Sponsor information

University of West Indies (Trinidad)
University/education

St Augustine Campus
St Augustine
-
Trinidad and Tobago

Website http://sta.uwi.edu/
ROR logo "ROR" https://ror.org/003kgv736

Funders

Funder type

University/education

University of West Indies (Trinidad) - St Augustine Campus

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan