Nutmeg extracts for painful diabetic neuropathy
| 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
Scientific
1 Cedar Avenue
Valsayn North
-
Trinidad and Tobago
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Can be found at http://nutpadin.webs.com/patientinformation.htm |
| Scientific title | Nutmeg extracts for painful diabetic neuropathy: a randomised controlled trial |
| Study acronym | NUTPADIN |
| Study objectives | Can 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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Nutmeg extracts |
| Primary outcome measure | 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 study start date | 01/09/2009 |
| Completion date | 30/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 64 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2009 |
| Date of final enrolment | 30/10/2009 |
Locations
Countries of recruitment
- Trinidad and Tobago
Study participating centre
1 Cedar Avenue
Valsayn North
-
Trinidad and Tobago
-
Trinidad and Tobago
Sponsor information
University of West Indies (Trinidad)
University/education
University/education
St Augustine Campus
St Augustine
-
Trinidad and Tobago
| Website | http://sta.uwi.edu/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
