NCT02145988

DLBS1033 Treatment in Diabetic With Peripheral Arterial Disease

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetes
• Peripheral Arterial Disease

Interventions

Type	Name	Description
DRUG	DLBS1033	Investigational drug or placebo will be given in addition to the standard therapy: aspirin at the dose of 80 mg, once daily, every day for twelve weeks of study period
DRUG	Placebo	Investigational drug or placebo will be given in addition to the standard therapy: aspirin at the dose of 80 mg, once daily, every day for twelve weeks of study period

Timeline

• Start date: 2015-06-03
• Primary completion: 2018-06-01
• Completion: 2018-07-01
• First posted: 2014-05-23
• Last updated: 2018-07-26

Locations

2 sites across 1 country: Indonesia