Health Condition 1: null- Diabetic peripheral neuropathy
Conditions
Interventions
Intervention1: Epalrestat: Epalrestat (150mg) :oral :once daily for maximum period of 90 days
Control Intervention1: Methylcobalamin: Methylcobalamin (1500 µg) per orally for 90 days
Sponsors
Primary Investigator
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex in the age group between 20 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 2. 3. Subjects who provide a written informed consent to abide by the study requirements.
Exclusion criteria
Exclusion criteria: 1. Patients with stage 3(N3)19i.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 conditions. 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 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 |
|---|---|
| The primary efficacy end point will be: â?¢ Percent change in modified neuropathy disability score from baseline Timepoint: Efficacy parameters- 0, 30 days, 60 days, 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety parameters: 1. ADR recording, 2. blood investigationsTimepoint: Safety parameters- 0, 90 days.;The secondary efficacy end points include: â?¢ Assessment of symptoms such as Loss of sensation Burning sensation Numbness Muscle cramp â?¢ Assessment of signs Tendon reflexes â?¢ Global assessment carried out by investigator at the end of 12 weeks. Timepoint: Efficacy parameters- 0, 30 days, 60 days, 90 days | — |
Countries
India
Contacts
Public ContactDr Sachin Devendrarao Shende
Govt. Medical College Aurangabad
Outcome results
None listed