Safety and efficacy of oral form of Neurotec in reduction of pain in patients with diabetic neuropathy
Phase 2
- Conditions
- Diabetic neuropathy.
- Registration Number
- IRCT138705221044N1
- Lead Sponsor
- Endocrine and Metablism research Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
having diabetic I or II
having pain and paresthesia interfering with every day activities
Diminished anckle reflex
Abnormal 128 Hz vibration test
Exclusion criteria:
Unwilling to sign a written consent Non-diabetic neuropathy Wound infection or infection in extremities ischaemic heart disease Heart failure reeiving immunosuppresive drugs, corticosteroids, chemotherapy, radiotherapy Alcohol and substance misuse Electrolyte disturbances History of known hypersensitivity to drugs Haemodialysis
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain measured by Visual Analogos Scale(VAS). Timepoint: baseline, 2, 4, 8, 12, 16 and 24 weeks. Method of measurement: measured by Visual Analogos Scale(VAS).
- Secondary Outcome Measures
Name Time Method Michigan Diabetic Neuropathy score. Timepoint: baseline, 2, 4, 8, 12, 16 and 24 weeks. Method of measurement: Questionaire.;UK Diabetic Neuropathy score. Timepoint: baseline, 2, 4, 8, 12, 16 and 24 weeks. Method of measurement: Questionaire.;Semmes-Weinstein monofilament test for peripheral sensory neuropathy. Timepoint: baseline, 2, 4, 8, 12, 16 and 24 weeks. Method of measurement: Monofilament test.