Comparative clinical trial of combination of Epalrestat 50 mg + Methylcobalamin 500 mcg with Epalrestat in the treatment of Diabetic neuropathy.
Phase 3
Completed
- Registration Number
- CTRI/2010/091/000223
- Lead Sponsor
- Aristo Pharmaceuticals pvt. ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 220
Inclusion Criteria
Age > 18 yrs, Type 2 diabetes treated with oral hypoglycemics with evidences of neuropathy, informed consent
Exclusion Criteria
no or low score for diabetic neuropathy, other type of neuropathy, other medications, patients with peripheral vascular diseases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the efficacy of the fixed dose combination with epalrestat alone.Timepoint: week 4, week 8, week 12
- Secondary Outcome Measures
Name Time Method regaining of 1. loss of sensation, 2. loss of sensation of heat and cold.Timepoint: week 4, week 8, week 12.