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Efficacy and Safety of DLBS1033 in Subjects With Type 2 Diabetes Mellitus

NCT01865474 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2016-08-04

No results posted yet for this study

Summary

This is a prospective, double-blind, randomized, and controlled study. The investigational product, DLBS1033 at a dose of 490 mg thrice daily or placebo, will be given for an 8-week course of therapy.

DLBS1033 effectively demonstrated fibrinolytic, fibrinogenolytic as well as antithrombotic activities. Hypercoagulation state with high fibrinogen level is usually found in diabetes mellitus patients.

Therefore, the hypothesis of interest of this study is that DLBS1033 will reduce fibrinogen level of diabetes mellitus patients better than that of the Control Group.

Conditions

Interventions

DRUG

DLBS1033

1 DLBS1033 tablet 490 mg thrice daily for 2 months

DRUG

placebo tablet of DLBS1033

1 placebo tablet of DLBS1033 thrice daily for 2 months

Sponsors & Collaborators

  • Dexa Medica Group

    lead INDUSTRY

Principal Investigators

  • Asman Manaf, Prof. Dr. dr., SpPD-KEMD · Department of Internal Medicine, Faculty of Medicine, University of Andalas/ dr. M. Djamil Padang Hospital, Padang, Sumatera Barat, Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01865474 on ClinicalTrials.gov