NCT02145988

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2 diabetes

Timeline
Completed

Started Jun 2015

Typical duration for phase_2 diabetes

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2014

Completed
1 year until next milestone

Study Start

First participant enrolled

June 3, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

3 years

First QC Date

May 21, 2014

Last Update Submit

July 24, 2018

Conditions

DiabetesPeripheral Arterial Disease

Keywords

DLBS1033Peripheral arterial diseaseAnkle-brachial index

Outcome Measures

Primary Outcomes (1)

  • Resting ankle-brachial index (ABI)

    The change of resting ABI

    Week 0 and 12

Secondary Outcomes (10)

  • Resting ABI

    Week 0 and 6

  • hs-CRP

    Week 0, 6, and 12

  • Thromboxane B2

    Week 0, 6, and 12

  • Fibrinogen

    Week 0, 6, and 12

  • d-dimer

    Week 0, 6, and 12

  • +5 more secondary outcomes

Study Arms (2)

DLBS1033

EXPERIMENTAL

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

PLACEBO COMPARATOR

Placebo tablet is administered one tablet three times daily, every day for twelve weeks of study period

Drug: Placebo

Interventions

DLBS1033DRUG

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
DLBS1033
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital

Denpasar, Bali, Indonesia

Location

Department of Internal Medicine, RSUD Wangaya

Denpasar, Bali, Indonesia

Location

MeSH Terms

Conditions

Diabetes MellitusPeripheral Arterial Disease

Interventions

DLBS 1033

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Ketut Suastika, Prof, SpPD, MD

    Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2014

First Posted

May 23, 2014

Study Start

June 3, 2015

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations

ID(2)