Health Condition 1: null- (Peripheral) diabetic neuropathy
Conditions
Interventions
Intervention1: Epalrestat: Sustained Release (150 mg) Tablet -------- Once daily before lunch for 3 months
Control Intervention1: Epalrestat: IR (50 mg) Tablet ------ 1 tablet thrice daily before meal
Sponsors
Themis Medicare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex in the age group between 18 to 70 years. 2. Diabetic patients stabilized on antidiabetic medication (on stable dose of antidiabetic drugs for the last 4 weeks) with stable glycemic control (HbA1c a) Motor nerve conduction velocity (MNCV) (less than normal, but > 40 m/s) b) Modified neuropathy disability score c) Total neuropathy score 3. Subjects who provide a written informed consent to abide by the study requirements.
Exclusion criteria
Exclusion criteria: 1. Patients with stage 3( N3) i.e. disabling neuropathy or presence of symptoms/ signs of foot ulcer. 2.Patients with diabetic neuropathy requiring hospital admission for management of neuropathy/ diabetic complications / any other disease condition 3. Patients presenting with primary cause of neurologic disorders other than diabetes (alcoholic neuropathy, carpal tunnel syndrome, sequelae of cerebrovascular disease). 4.Patients presenting with arteriosclerosis obliterans (ankle brachial pressure index of < 0.8) 5. Patients with known hypersensitivity to any of the ingredients of the test / comparator formulation. 6. Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases. 7. Patients with H/O alcohol/ drug abuse 8. Pregnant and lactating females. 9. Simultaneous participation in another clinical study or if they were receiving other experimental medications for diabetic neuropathy, prostaglandin E1 preparations, or any other medication that affects symptoms of diabetic neuropathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified neuropathy disability scoreTimepoint: Efficacy parameters : 0, 30 days, 60 days, 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| (a)Pressure perception threshold (b) Pain / symptom intensity will be assessed on visual analogue scale (VAS) (c) Relief of pain / any other symptom will be assessed on Visual Analogue Scale (d) Need of rescue medication evaluated as number of episodes patient needed T.Diazepam / T.Carbamazepine (e) Time needed for the patient to be symptom free.Timepoint: Safety parameters : 0, 90 days | — |
Countries
India
Contacts
Public ContactDr Sumedh M Gaikwad
Outcome results
None listed