NCT01865474|CompletedPhase 4
Efficacy and Safety of DLBS1033 in Subjects With Type 2 Diabetes Mellitus
DLBS1033 Therapy in Improving Hypercoagulation State in Subjects With Type 2 Diabetes Mellitus
Loading search results
DLBS1033 Therapy in Improving Hypercoagulation State in Subjects With Type 2 Diabetes Mellitus
Sponsor study identifier
interventional
122
1 country
1
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
Actual (reported)Study Completion
June 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
May 28, 2013
Actual (reported)May 31, 2013
Actual (reported)June 2016
Actual (reported)June 2016
Actual (reported)Fibrinogen level reduction
Fibrinogen level reduction from baseline to the end of study (Week 8th)
8 weeks
Change of D-dimer
4 weeks and 8 weeks
Change of von Willebrand Factor activity
4 weeks and 8 weeks
Change of hs-CRP level
4 weeks and 8 weeks
Change of HbA1c
8 weeks
Liver function
8 weeks
DLBS1033 bioactive fraction tablet 490 mg thrice daily
Placebo tablet of DLBS1033, thrice daily
1 DLBS1033 tablet 490 mg thrice daily for 2 months
1 placebo tablet of DLBS1033 thrice daily for 2 months
Department of Internal Medicine, Faculty of Medicine, University of Andalas/ dr. M. Djamil Padang Hospital
Padang, West Sumatra, Indonesia
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
122 participants (actual enrollment reported by the registry).
First Submitted
May 28, 2013
First Posted
May 31, 2013
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 2016
Actual (reported)Study Completion
June 2016
Actual (reported)Last Updated
August 4, 2016
Record last verified: 2016-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: