The effect of Neuragen® on neuropathic pain: Double-blind, placebo-controlled clinical trial
| ISRCTN | ISRCTN20181108 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20181108 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/06/2008
- Registration date
- 09/06/2008
- Last edited
- 16/08/2011
- 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
Not provided at time of registration
Contact information
Dr Li Li
Scientific
Scientific
Department of Kinesiology
Louisiana State University
Baton Rouge
70803
United States of America
Study information
| Study design | Double-blind, randomised, placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study hypothesis | Neuragen® reduces neuropathic pain more than placebo. |
| Ethics approval(s) | Institutional Review Board, Louisiana State University. Date of approval: 09/28/2007 (ref: 2754) |
| Condition | Peripheral neuropathy |
| Intervention | Topical application of Neuragen® vs placebo. Neuragen®/placebo is applied once each in random order and in a double-blind fashion. The applications are at least one week apart form each other. Pain is measured 30 minutes before and after the application, and tracked every hour for 8 hours. Total duration of follow-up: 8 hours after each application |
| Intervention type | Other |
| Primary outcome measure | Foot sole pain on 11-point numerical pain scale, measured 30 minutes before and after the Neuragen®/placebo application, and tracked every hour for 8 hours. |
| Secondary outcome measures | Duration of pain reduction. Pain is measured 30 minutes before and after the application, and tracked every hour for 8 hours. |
| Overall study start date | 01/10/2007 |
| Overall study end date | 27/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Participant inclusion criteria | 1. Both males and females, over 21 2. Diagnosed neuropathic pain for more three months 3. Pain level between 3-8 on a 0-10 visual pain scale 4. Does not have mental and communication impairments |
| Participant exclusion criteria | 1. Pregnant 2. Have other types of pain 3. Skin condition 4. Central nerve impairment |
| Recruitment start date | 01/10/2007 |
| Recruitment end date | 27/09/2008 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Department of Kinesiology
Baton Rouge
70803
United States of America
70803
United States of America
Sponsor information
Origin BioMed, Inc. (Canada)
Industry
Industry
5162 Duke Street
Suite 300
Halifax
B3J 1N7
Canada
| Website | http://originbiomed.com |
|---|---|
"ROR" |
https://ror.org/008mcnd42 |
Funders
Funder type
Industry
Origin BioMed, Inc. (Canada)
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 |
