Comparative clinical trial of combination of Epalrestat 50 mg + Methylcobalamin 500 mcg with Epalrestat in the treatment of Diabetic neuropathy.

A phase 3, single blind, randomized, comparative, multicentric clinical study to evaluate efficacy and safety of FDC of Epalrestat 50 mg + Methylcobalamin 500 mcg with Epalrestat 50 mg in the treatment of patients with Diabetic neuropathy.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000223

Enrollment

220

Registered

2010-06-18

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

None listed

Interventions

Intervention1: FDC of epalrestat + methylcobalamin: one tablet thrice daily for 12 weeks Control Intervention1: epalrestat: one tablet thrice daily for 12 weeks

Eligibility

Inclusion criteria

Inclusion criteria: Age > 18 yrs, Type 2 diabetes treated with oral hypoglycemics with evidences of neuropathy, informed consent

Exclusion criteria

Exclusion criteria: no or low score for diabetic neuropathy, other type of neuropathy, other medications, patients with peripheral vascular diseases.

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of the fixed dose combination with epalrestat alone.Timepoint: week 4, week 8, week 12	—

Secondary

Measure	Time frame
regaining of 1. loss of sensation, 2. loss of sensation of heat and cold.Timepoint: week 4, week 8, week 12.	—

Countries

India

Contacts

Public ContactDr Manish Maladkar

scientific@aristopharma.org02226739999

Outcome results