Type 2 Diabetes Mellitus Clinical Trial
Official title:
DLBS1033 Therapy in Improving Hypercoagulation State in Subjects With Type 2 Diabetes Mellitus
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.
There will be 2 groups of treatment, each consisting of 68 subjects, with the treatment
regimens as the following:
Treatment I : DLBS1033 bioactive fraction tablet @ 490 mg, three times daily. Treatment II :
Placebo tablet of DLBS1033, three times daily.
Clinical examination to evaluate the efficacy of the investigational drug will be performed
at baseline and every follow-up visit (at interval of 4 weeks) over the 8 weeks of study
period. All subjects will be advised to follow such a lifestyle modification throughout the
study period.
All subjects will be under direct supervision of a medical doctor during the study period.
During the study period, anti-diabetes treatment taken by study subjects should still be
continued. Other treatment related to subjects' concomitant illnesses, such as hypertension,
and/or dyslipidemia, is allowed during subjects' participation in the study.
Other medication such as anti-platelets, fibrinolytic agents and anti-coagulants, or other
treatment including herbals/alternatives which may affect haemostatic system, are not
allowed to be used during the study period.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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