- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02145988
DLBS1033 Treatment in Diabetic With Peripheral Arterial Disease
Improvement of Ankle-Brachial Index by DLBS1033 Treatment in Diabetic Patients With Peripheral Arterial Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Bali
-
Denpasar, Bali, Indonesia
- Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital
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Denpasar, Bali, Indonesia
- Department of Internal Medicine, RSUD Wangaya
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed informed consent before any trial related activities.
- Male or female subjects of 40 - 65 years of age.
- Diagnosis of diabetes mellitus defined as HbA1c level of ≥ 6.5% (for newly diagnosed diabetes) or based on medical history.
- Presence of peripheral arterial disease with resting ankle-brachial index (ABI) of 0.41-0.90 inclusive
Exclusion Criteria:
- Females of childbearing potential: pregnancy, breast-feeding, and the intention of becoming pregnant.
- Recent stroke attack, myocardial infarction/unstable angina/acute coronary syndrome, coronary artery bypass surgery (CABG) or percutaneous transluminal coronary angioplasty (PTCA)/stent within 3 (three) months prior to screening.
- Impaired liver function: serum ALT > 2.5 times upper limit of normal.
- Impaired renal function: serum creatinine ≥ 1.5 times upper limit of normal.
- Concomitant use of other antithrombosis drugs or any antiplatelets other than the study medication.
- Subjects with concurrent herbal (alternative) medicines or food supplements
- Subjects with any other disease state, including chronic or acute systemic infections, uncontrolled illnesses or other chronic diseases, which judged by the investigator, could interfere with trial participation or trial evaluation.
- Subjects with high risk of bleeding:
- Subjects with prior experience with DLBS1033 or other oral lumbrokinase products.
- Subjects with known or suspected allergy to any of study medications used in the study, including other lumbrokinase products.
- Subjects with known or suspected allergy or resistant to aspirin.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DLBS1033
DLBS1033 tablet is administered at the dose of 490 mg, one tablet three times daily, every day for twelve weeks of study period
|
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
Other Names:
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Placebo Comparator: Placebo
Placebo tablet is administered one tablet three times daily, every day for twelve weeks of study period
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resting ankle-brachial index (ABI)
Time Frame: Week 0 and 12
|
The change of resting ABI
|
Week 0 and 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resting ABI
Time Frame: Week 0 and 6
|
The change of resting ABI
|
Week 0 and 6
|
hs-CRP
Time Frame: Week 0, 6, and 12
|
The change of hs-CRP
|
Week 0, 6, and 12
|
Thromboxane B2
Time Frame: Week 0, 6, and 12
|
The change of thromboxane B2
|
Week 0, 6, and 12
|
Fibrinogen
Time Frame: Week 0, 6, and 12
|
The change of fibrinogen
|
Week 0, 6, and 12
|
d-dimer
Time Frame: Week 0, 6, and 12
|
The change of d-dimer
|
Week 0, 6, and 12
|
Routine hematology
Time Frame: Week 0, 6, and 12
|
Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count
|
Week 0, 6, and 12
|
Liver function
Time Frame: Week 0 and 12
|
Liver function measured includes: serum ALT, AST, and alkaline phosphatase
|
Week 0 and 12
|
Renal function
Time Frame: Week 0 and 12
|
Renal function measured includes: serum creatinine and blood urea nitrogen (BUN)
|
Week 0 and 12
|
Haemostasis parameters
Time Frame: Week 0, 6, and 12
|
Haemostasis parameters measured includes: prothrombin time (PT) and activated partial thromboplastin time (aPTT)
|
Week 0, 6, and 12
|
Adverse events
Time Frame: Week 0 - 12
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Adverse events, including bleeding events, will be observed and carefully evaluated along the course of the study
|
Week 0 - 12
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ketut Suastika, Prof, SpPD, MD, Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DLBS1033-0312
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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