DLBS1033 Treatment in Diabetic With Peripheral Arterial Disease

Diabetes Clinical Trial

Official title: Improvement of Ankle-Brachial Index by DLBS1033 Treatment in Diabetic Patients With Peripheral Arterial Disease

Status Terminated

Clinical Trial Summary

This is a prospective, randomized, double-blind, double-dummy, and controlled study of DLBS1033 for the improvement of ankle-brachial index in diabetic patients with peripheral arterial disease (PAD). It is hypothesized that the addition of DLBS1033 on top of aspirin treatment will augment significantly the resting ABI in diabetes patient with PAD in comparison with that of aspirin alone.

Clinical Trial Description

Subjects in this study will be screened consecutively and eligible subjects will be randomized to receive aspirin tablet 80 mg once daily and either the investigational drug (DLBS1033 tablet 490 mg three times daily) or its placebo, for 12 weeks.

Diabetic subjects who have been being under therapy with aspirin can directly start with study treatment. For those who are currently not under therapy with aspirin, there will be a run-in period during which they will receive (or be switched to) aspirin treatment, for two weeks. After then, they will receive study medication.

Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at baseline and at the interval of six weeks over the twelve week-course of therapy. ;

Related Conditions & MeSH terms

• Diabetes
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

• NCT number: NCT02145988
• Study type: Interventional
• Source: Dexa Medica Group
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: June 3, 2015
• Completion date: July 2018