Recruitment

Recruitment Status
Terminated
Estimated Enrollment
114

Summary

Conditions
  • Diabetes
  • Peripheral Arterial Disease
Type
Interventional
Phase
Phase 2 & Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Min Age
40
Max Age
65
Gender
Both

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 w...

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.

Locations

Denpasar, Bali
Denpasar, Bali
Denpasar, Bali
Denpasar, Bali

Tracking Information

NCT #
NCT02145988
Collaborators
Not Provided
Investigators
  • Principal Investigator: Ketut Suastika, Prof, SpPD, MD Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital
  • Ketut Suastika, Prof, SpPD, MD Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital