The effect of Neuragen® on neuropathic pain: Double-blind, placebo-controlled clinical trial
| ISRCTN | ISRCTN20181108 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20181108 |
| Protocol serial number | N/A |
| Sponsor | Origin BioMed, Inc. (Canada) |
| Funder | Origin BioMed, Inc. (Canada) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind, randomised, placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Neuragen® reduces neuropathic pain more than placebo. |
| Ethics approval(s) | Institutional Review Board, Louisiana State University. Date of approval: 09/28/2007 (ref: 2754) |
| Health condition(s) or problem(s) studied | 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(s) |
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. |
| Key secondary outcome measure(s) |
Duration of pain reduction. Pain is measured 30 minutes before and after the application, and tracked every hour for 8 hours. |
| Completion date | 27/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Key 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 |
| Key exclusion criteria | 1. Pregnant 2. Have other types of pain 3. Skin condition 4. Central nerve impairment |
| Date of first enrolment | 01/10/2007 |
| Date of final enrolment | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
