Painful Diabetic Neuropathy Clinical Trial
Official title:
Study of Topical Preparation of Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy
Verified date | April 2013 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objectives of this study are to determine efficacy and safety of 0.75% topical capsaicin nanoparticle preparation versus placebo in patient with painful diabetic neuropathy.
Status | Unknown status |
Enrollment | 60 |
Est. completion date | December 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - History of type 2 Diabetes mellitus - Peripheral neuropathy - Stabilized on pain medication for at least one month - No previous invasive intervention for pain relief Exclusion Criteria: - Local wound or any skin abnormality in the applicable area - Allergic to capsaicin - Refuse to participate or give consent - Has other significant disease or receive medication that may worsen neuropathy |
Country | Name | City | State |
---|---|---|---|
Thailand | Ramathibodi Hospital | Bangkok | |
Thailand | Thammasat University Hospital | Pathumthani |
Lead Sponsor | Collaborator |
---|---|
Mahidol University | Thailand Research Fund |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain relief from pain score reduction, using visual analog scale (VAS) | 12 weeks |
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