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DLBS1033 Treatment in Diabetic With Peripheral Arterial Disease

NCT02145988 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2018-07-26

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Dexa Medica Group

    lead INDUSTRY

Principal Investigators

  • Ketut Suastika, Prof, SpPD, MD · Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-03
Primary Completion
2018-06-30
Completion
2018-07-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02145988 on ClinicalTrials.gov