Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dexa Medica Group
ClinicalTrials.gov Identifier:
NCT01790997
First received: February 12, 2013
Last updated: January 29, 2014
Last verified: January 2014

February 12, 2013
January 29, 2014
May 2012
November 2013   (final data collection date for primary outcome measure)
Change in INR value [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
Change in INR (international normalized ratio) value from baseline to end of study (Month 3rd)
Same as current
Complete list of historical versions of study NCT01790997 on ClinicalTrials.gov Archive Site
  • Change in PT [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    Change in PT (prothrombin time) from baseline to end of study (Month 3rd)
  • Change in aPTT [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    Change in aPTT (activated-partial thromboplastin time) from baseline to end of study (Month 3rd)
  • Change in Gadjah Mada Stroke Scale [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    Change in Gadjah Mada Stroke Scale from baseline to end of study (Month 3rd)
  • Change in Barthel Index [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    Change in Barthel Index from baseline to end of study (Month 3rd)
Same as current
Not Provided
Not Provided
 
Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke
The Role of DLBS1033 in Evaluating Bleeding Profile and Clinical Outcome in Patients With Acute Ischemic Stroke: Comparison With Aspirin and Clopidogrel

This is a 3-arm, prospective, randomized, double-blind, and controlled clinical study, with 3 months of treatment to evaluate efficacy of DLBS1033 in bleeding profile and clinical outcome in patients with acute ischemic stroke compared with aspirin and clopidogrel, as active controls.

There will be 3 groups of treatment; each group will consist of 43 subjects with the treatment regimens :

  • Treatment I : 1 tablet of DLBS1033 490 mg thrice daily, after meal
  • Treatment II : 1 tablet of aspirin 80 mg once daily, after meal
  • Treatment III : 1 tablet of clopidogrel 75 mg once daily, after meal

Bleeding profile (by measuring INR value, PT, and aPTT) and clinical outcome (by measuring Gadjah Mada Stroke Scale and Barthel Index) to evaluate the efficacy of the investigational drug will be performed at baseline and end of study (Month 3rd). General condition of the subjects will be followed-up every month over three months of study medication.

Physiotherapy will be provided to the subjects by the assigned Physiotherapist.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Ischemic Stroke
  • Drug: DLBS1033
    1 tablet of DLBS1033 490 mg thrice daily, after meal
  • Drug: Aspirin
    1 tablet of aspirin 80 mg once daily, after meal
  • Drug: Clopidogrel
    1 tablet of clopidogrel 75 mg once daily, after meal
  • Experimental: Treatment I
    1 tablet of DLBS1033 490 mg thrice daily, after meal
    Intervention: Drug: DLBS1033
  • Active Comparator: Treatment II
    1 tablet of aspirin 80 mg once daily, after meal
    Intervention: Drug: Aspirin
  • Active Comparator: Treatment III
    1 tablet of clopidogrel 75 mg once daily, after meal
    Intervention: Drug: Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
December 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female subjects aged 20-80 years old
  • Having non-bleeding stroke in CT scan examination
  • Having stroke attack onset ≤ 24 hours
  • Living in 100 km from RSUP Dr Sardjito Jogjakarta

Exclusion Criteria:

  • Having recurrence stroke
  • Having Transient Ischemic Attack (TIA)
  • Have been regularly taking anti-aggregation agent
  • Having intracerebral and subarachnoid bleeding stroke
  • Subjects and their family do not know when the stroke symptoms appeared
  • History of haemostatis disorder
  • History of or will have surgery within 6 months prior to screening
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
NCT01790997
DLBS1033-UST-001.11
No
Dexa Medica Group
Dexa Medica Group
Not Provided
Principal Investigator: Ismail Setyopranoto, dr., SpS(K) Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital, Jogjakarta, Indonesia
Dexa Medica Group
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP