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Efficacy of Epalrestat and Benfotiamine in Reducing Nerve Damage in Patients with Diabetes Mellitus (Type 2 Diabetes)

Efficacy of Epalrestat and Benfotiamine in Patients with Diabetic Neuropathy. A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009577
Enrollment
84
Registered
2017-08-31
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- Diabetic Neuropathy

Interventions

Intervention1: Epalrestat: Epalrestat 50mg three times a day for 3 months in addition to standard background therapy Intervention2: Benfotiamine: Benfotiamine 100mg three times a day for 3 months in a

Sponsors

JIPMER Intramural fund
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes mellitus presenting to the diabetology clinic of Medicine outpatient department (OPD) diagnosed to have diabetic neuropathy with symptoms of paresthesia, dysesthesia, numbness, hypoesthesia (but not anesthesia).

Exclusion criteria

Exclusion criteria: 1. Patients with peripheral vascular diseases 2. Patients taking Vitamin B12, Vitamin B6, alpha lipoic acid, gabapentin, pregabalin, duloxetine and amitryptiline. 3. Patients with renal and hepatic dysfunction and congestive cardiac failure 4. Patients without reasonably good levels of HbA1c( >8.5)

Design outcomes

Primary

MeasureTime frame
1.Sensory nerve conduction velocity in median and sural nerves 2. Motor nerve conduction velocity in median and common peroneal nervesTimepoint: 1.Baseline, 3rd month end 2.Baseline, 3rd month end—

Secondary

MeasureTime frame
1. Sensory Nerve Action Potential (SNAP) - Median and Sural nerves 2. F Wave Latency (FWL) - Median and Common Peroneal nerves 3. Compound Muscle Action Potential (CMAP) - Median and Common Peroneal nerves 4. Distal Motor Latency- Median and Common Peroneal Nerves 5. Vibration Perception Threshold- Median, Common Peroneal and Sural nerves 6. Diabetic Neuropathy Symptom Score (DNS) 7. Toronto Clinical Scoring System (TCSS) 8. Adverse Effect ProfileTimepoint: 1. Baseline, at the end of 3rd month 2. Baseline, at the end of 3rd month 3. Baseline, at the end of 3rd month 4. Baseline, at the end of 3rd month 5. Baseline, at the end of 3rd month 6. Baseline, at the end of 3rd month 7. Baseline, at the end of 3rd month 8. 1st, 2nd and 3rd month—

Countries

India

Contacts

Public ContactDr Rajeswari Aghoram

JIPMER

drsmanikandan001@gmail.com9443774648

Outcome results

None listed

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