A Phase 2/3 interventional study of DLBS1033 and Placebo in Diabetes and Peripheral Arterial Disease, sponsored by Dexa Medica Group. Terminated at 2 sites in Indonesia. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-07-26.
Sponsored by Dexa Medica Group · Phase 2/3, Interventional, and Treatment
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.
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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 11 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Dexa Medica Group is the lead sponsor of 39 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
DLBS1033 tablet is administered at the dose of 490 mg, one tablet three times daily, every day for twelve weeks of study period
Drug: DLBS1033
Placebo tablet is administered one tablet three times 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
Also known as: Disolf
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
Resting ankle-brachial index (ABI)
The change of resting ABI
Time frame: Week 0 and 12
Resting ABI
The change of resting ABI
Time frame: Week 0 and 6
hs-CRP
The change of hs-CRP
Time frame: Week 0, 6, and 12
Thromboxane B2
The change of thromboxane B2
Time frame: Week 0, 6, and 12
Fibrinogen
The change of fibrinogen
Time frame: Week 0, 6, and 12
d-dimer
The change of d-dimer
Time frame: Week 0, 6, and 12
Routine hematology
Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count
Time frame: Week 0, 6, and 12
Liver function
Liver function measured includes: serum ALT, AST, and alkaline phosphatase
Time frame: Week 0 and 12
Renal function
Renal function measured includes: serum creatinine and blood urea nitrogen (BUN)
Time frame: Week 0 and 12
Haemostasis parameters
Haemostasis parameters measured includes: prothrombin time (PT) and activated partial thromboplastin time (aPTT)
Time frame: Week 0, 6, and 12
Adverse events
Adverse events, including bleeding events, will be observed and carefully evaluated along the course of the study
Time frame: Week 0 - 12
This study is terminated, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Dexa Medica Group