Study of the efficacy and safety of Epalrestat to Pregabalin in patients suffering from painful diabetic peripheral neuropathy.

A prospective, controlled, randomized, double blind, comparative, parallel, 2-arms study to evaluate the efficacy and safety of Epalrestat (150 mg) compared to Pregabalin (600 mg) in patients suffering from painful diabetic peripheral neuropathy.

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/05/003646

Enrollment

240

Registered

2013-05-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Painful diabetic peripheral neuropathy

Interventions

Intervention1: Epalrestat (150mg): Epalrestat (150mg) :oral :once daily for maximum period of 90 days Control Intervention1: Pregabalin (600 mg): Pregabalin (600 mg) :oral :once daily for maximum per

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 whose pain score of at least 40 mm on the 100 mm visual analogue scale (VAS)

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 with history of or current diagnosis of mania, bipolar disorder, obsessive-compulsive disorder, or posttraumatic stress disorder or to be at risk of suicide judged before randomization. 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
1)Primary Efficacy Parameters: a.Pain severity as measured on 11 point Visual Analogue scale (VAS) b.Modified neuropathy disability scoreTimepoint: Efficacy parameters- 0, 30 days, 60 days, 90 days	—

Secondary

Measure	Time frame
2)Secondary Efficacy Parameters: a. Other symptom intensity will be assessed on VAS b. Relief of Pain / any other symptom will be assessed on VAS c. Patient Global Impression of Change (PGIC), and Clinical Global Impression of Change (CGIC)Timepoint: Efficacy parameters- 0, 30 days, 60 days, 90 days ;Safety parameters: 1. ADR recording, 2. blood investigationsTimepoint: Safety parameters- 0, 90 days.	—

Measure

Time frame

2)Secondary Efficacy Parameters: a. Other symptom intensity will be assessed on VAS b. Relief of Pain / any other symptom will be assessed on VAS c. Patient Global Impression of Change (PGIC), and Clinical Global Impression of Change (CGIC)Timepoint: Efficacy parameters- 0, 30 days, 60 days, 90 days ;Safety parameters: 1. ADR recording, 2. blood investigationsTimepoint: Safety parameters- 0, 90 days.

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Countries

India

Contacts

Public ContactDr Sachin Devendrarao Shende

Govt. Medical College Aurangabad.

sachindshende@yahoo.co.in09579016106

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026