A clinical trial study to evaluate the efficacy and safety of Epalrestat 150 mg Sustained Release Tablets in patients suffering from (peripheral) diabetic neuropathy
- Conditions
- Health Condition 1: null- (Peripheral) diabetic neuropathy
- Registration Number
- CTRI/2010/091/001479
- Lead Sponsor
- Themis Medicare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 200
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 < 9%, with _0.5% variation in the previous 3 months) presenting with subjective symptoms of peripheral neuropathy confirmed on the basis of the following criteria:
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Modified neuropathy disability scoreTimepoint: Efficacy parameters : 0, 30 days, 60 days, 90 days
- Secondary Outcome Measures
Name Time Method (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