IRCT138802201044N3
Completed
Phase 3
Multi-Centre, Randomised, Double-Blind, Placebo Controlled Trial of the Effect of Neurotec in Symptomatic Diabetic Neuropathy
ParsRoos Company0 sites300 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Diabetic Neuropathy.
- Sponsor
- ParsRoos Company
- Enrollment
- 300
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria:
- •Pain equivalent to 4 or more on a numerical scale between 0 and 10, Diagnosis of Diabetes Mellitus (Type 1 or 2\) defined by American Diabetes Association criteria for at least 3 years, Haemoglobin A1C less than 10%, History of Diabetic Neuropathy for more than a year, Age more than 18 years and less than 60, diagnosis of neuropathy based on Michigan Neuropathy Screening Instrument
Exclusion Criteria
- •Presence of uncontrolled or poor controlled DM, Presence of neuropathy due to other causes than DM, Receiving any investigational drug within 30 days prior to screening, Presence of active or infected diabetic wound, Amputation, Presence of any other systemic or chronic diseases such as: Myopathy, Vasculitis, Peripheral Vascular Diseases, Chronic hepatic or renal diseases, clinically complicating pulmonary, Cardiac, Hematologic, Gastrointestinal, Endocrine disease or Malignancy, Symptomatic degenerative joint disease, active radiculopathy or discopathy, spinal stenosis , active degenerative disc diseases, chronic sciatalgia, sacroiliac joint dysfunction or any chronic painful condition involving lower extremities, apparent or diagnosed psychological problem such as anxiety or depression, Diabetic Retinopathy or retinal haemorrhage, Pregnancy or intention of becoming pregnant during the study period (9 months), Inability to give informed consent according to the agreed process, Corticosteroid therapy, Any drug hypersensitivity, Radiotherapy, Chemotherapy or any immuosuppressive drug use, Electrolyte imbalance
Outcomes
Primary Outcomes
Not specified
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