A Phase 4 interventional study of DLBS1033 and placebo tablet of DLBS1033 in Type 2 Diabetes Mellitus, sponsored by Dexa Medica Group. Completed at 1 site in Indonesia. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-08-04.
Sponsored by Dexa Medica Group · Phase 4, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 122 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Dexa Medica Group is the lead sponsor of 39 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
For females of childbearing potential: Pregnancy, breast-feeding, the intention of becoming pregnant.
DLBS1033 bioactive fraction tablet 490 mg thrice daily
Drug: DLBS1033
Placebo tablet of DLBS1033, thrice daily
Drug: placebo tablet of DLBS1033
1 DLBS1033 tablet 490 mg thrice daily for 2 months
Also known as: Disolf
1 placebo tablet of DLBS1033 thrice daily for 2 months
Also known as: placebo tablet of Disolf
Fibrinogen level reduction
Fibrinogen level reduction from baseline to the end of study (Week 8th)
Time frame: 8 weeks
Change of D-dimer
Change of D-dimer from baseline to every follow-up visit
Time frame: 4 weeks and 8 weeks
Change of von Willebrand Factor activity
Change of von Willebrand Factor activity from baseline to every follow-up visit.
Time frame: 4 weeks and 8 weeks
Change of hs-CRP level
Change of hs-CRP level from baseline to every follow-up visit.
Time frame: 4 weeks and 8 weeks
Change of HbA1c
Change of HbA1c from baseline to end of study (Week 8th).
Time frame: 8 weeks
Liver function
Liver function (serum ALT, AST,γ-glutamyl transferase, alkaline phosphatase) at baseline and end of study (Week 8th)
Time frame: 8 weeks
Renal function
Renal function (serum creatinine, BUN) at baseline and end of study (Week 8th)
Time frame: 8 weeks
Prothrombin Time (PT)
Prothrombin time from baseline to every follow-up visit
Time frame: 4 weeks and 8 weeks
Activated partial thromboplastin time (aPTT)
Activated partial thromboplastin time (aPTT)from baseline to every follow-up visit
Time frame: 4 weeks and 8 weeks
Adverse events
Adverse events (mainly: GI bleeding, and other bleeding events) from baseline to every follow-up visit
Time frame: 4 weeks and 8 weeks (during 8 weeks)
Change of Thromboxane-B2 level
Change of Thromboxane-B2 level from baseline to every follow-up visit (as an indirect indicator to assess the effect of study treatment on TxA2)
Time frame: 4 weeks and 8 weeks
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Dexa Medica Group