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Trial record 80 of 87 for:    ASPIRIN AND thromboxane

DLBS1033 Treatment in Diabetic With Peripheral Arterial Disease

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ClinicalTrials.gov Identifier: NCT02145988
Recruitment Status : Terminated (Recruitment rate is unexpectedly too low (insufficient number of eligible patients).)
First Posted : May 23, 2014
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Dexa Medica Group

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Peripheral Arterial Disease Drug: DLBS1033 Drug: Placebo Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improvement of Ankle-Brachial Index by DLBS1033 Treatment in Diabetic Patients With Peripheral Arterial Disease
Actual Study Start Date : June 3, 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


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
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
Other Name: Disolf

Placebo Comparator: Placebo
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




Primary Outcome Measures :
  1. Resting ankle-brachial index (ABI) [ Time Frame: Week 0 and 12 ]
    The change of resting ABI


Secondary Outcome Measures :
  1. Resting ABI [ Time Frame: Week 0 and 6 ]
    The change of resting ABI

  2. hs-CRP [ Time Frame: Week 0, 6, and 12 ]
    The change of hs-CRP

  3. Thromboxane B2 [ Time Frame: Week 0, 6, and 12 ]
    The change of thromboxane B2

  4. Fibrinogen [ Time Frame: Week 0, 6, and 12 ]
    The change of fibrinogen

  5. d-dimer [ Time Frame: Week 0, 6, and 12 ]
    The change of d-dimer

  6. Routine hematology [ Time Frame: Week 0, 6, and 12 ]
    Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count

  7. Liver function [ Time Frame: Week 0 and 12 ]
    Liver function measured includes: serum ALT, AST, and alkaline phosphatase

  8. Renal function [ Time Frame: Week 0 and 12 ]
    Renal function measured includes: serum creatinine and blood urea nitrogen (BUN)

  9. Haemostasis parameters [ Time Frame: Week 0, 6, and 12 ]
    Haemostasis parameters measured includes: prothrombin time (PT) and activated partial thromboplastin time (aPTT)

  10. Adverse events [ Time Frame: Week 0 - 12 ]
    Adverse events, including bleeding events, will be observed and carefully evaluated along the course of the study



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02145988


Locations
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Indonesia
Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital
Denpasar, Bali, Indonesia
Department of Internal Medicine, RSUD Wangaya
Denpasar, Bali, Indonesia
Sponsors and Collaborators
Dexa Medica Group
Investigators
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Principal Investigator: Ketut Suastika, Prof, SpPD, MD Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital

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Responsible Party: Dexa Medica Group
ClinicalTrials.gov Identifier: NCT02145988     History of Changes
Other Study ID Numbers: DLBS1033-0312
First Posted: May 23, 2014    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Keywords provided by Dexa Medica Group:
DLBS1033
Peripheral arterial disease
Ankle-brachial index
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases