Condition category
Nervous System Diseases
Date applied
21/07/2009
Date assigned
05/08/2009
Last edited
25/08/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shastri Motilal

ORCID ID

Contact details

1 Cedar Avenue
Valsayn North
-
Trinidad and Tobago

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

http://sta.uwi.edu/

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

Publication citations

Additional files

Editorial Notes