search
Back to results

DLBS1033 for the Treatment of Acute Ischemic Stroke

Primary Purpose

Acute Ischemic Stroke

Status
Terminated
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Placebo
DLBS1033
Sponsored by
Dexa Medica Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring DLBS1033, acute ischemic stroke, MRS, mNIHSS

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subjects with age of 18-75 years .
  • Has been diagnosed with acute ischemic stroke clinically confirmed by CT scan.
  • Modified National Institutes of Health Stroke Scale (mNIHSS) score >= 5.
  • Patients present at hospital and receiving first dose of study medication within 72 hours after the onset of the stroke symptoms.
  • Able to take oral medication.

Exclusion Criteria:

  • For females of childbearing potential: pregnancy and lactation period.
  • History of or current hemorrhagic stroke (within the last 3 months).
  • Transient ischemic stroke (TIA).
  • Patients with seizure at the onset of stroke.
  • History of serious head injury within the last 3 months.
  • History of major surgery within the last 3 months.
  • Serious cardiovascular conditions, such as myocardial infarction, CHF grade III and IV (NYHA classification), aorta dissection, and atrial fibrillation within the last 6 months.
  • Presence of severe renal or hepatic dysfunction
  • Presence of acute or chronic infections.
  • Thrombocytopenia (thrombocytes level < 150.000/ul).
  • Patients with higher risks of bleeding.
  • Uncontrolled hypertension (systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg).
  • Random plasma glucose >= 200 mg/dL.
  • Current or regular use of oral anticoagulants, antiplatelets other than study medication, and herbal medicines.
  • Hypersensitive to the investigational product(s).

Sites / Locations

  • RSUD R. Syamsudin, SH

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Group

DLBS1033 Group

Arm Description

Placebo will be administered orally, 3 x 1 tablet daily, for 8 days of study period

DLBS1033 will be administered orally, 3 x 1 tablet daily, for 8 days of study period

Outcomes

Primary Outcome Measures

Improvement in mNIHSS score
Change in functional outcomes as measured by The Modified National Institute of Health Stroke Scale (mNIHSS) from its baseline value

Secondary Outcome Measures

Improvement in MRS
Change in functional outcomes as measured by Modified Rankin Scale (MRS) from its baseline value
Improvement in fibrinogen level
Change in haemostatic parameter as measured by fibrinogen level from its baseline value
Improvement in d-dimer level
Change in haemostatic parameter as measured by d-dimer level from its baseline value
Liver function
Liver function measured will be: serum AST, ALT, G-GT, total bilirubin
Renal function
Renal function measured will be serum creatinine
Routine hematology
Routine hematology measured will be: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count
Hemostasis parameters
Hemostasis parameters measured will be: PT and aPTT
Adverse events
Adverse events, including bleeding events, will be observed and carefully evaluated during the expected average of 7 days of study treatment.

Full Information

First Posted
February 3, 2015
Last Updated
May 2, 2017
Sponsor
Dexa Medica Group
search

1. Study Identification

Unique Protocol Identification Number
NCT02362984
Brief Title
DLBS1033 for the Treatment of Acute Ischemic Stroke
Official Title
The Role of DLBS1033 in the Management of Acute Ischemic Stroke Patients: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Major technical hindrance in recruitment.
Study Start Date
October 2014 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dexa Medica Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective, randomized, double-blind, and controlled clinical study to investigate the effects of DLBS1033 in conjunction with standard therapy compared to standard therapy alone in acute ischemic stroke patients.
Detailed Description
Patients included into the study will be randomized into two groups and receive either standard therapy alone (as control group) or standard therapy plus DLBS1033 at a dose of 490 mg three times daily (as DLBS1033 group). Standard therapy used in the study will consist of: aspirin 80 mg, simvastatin 20 mg, vitamin B complex, and citicholine 250 mg/2 mL twice daily. After hospital admission and diagnosis, patient will be handled according to the standard management for acute ischemic stroke applicable in the hospital. Right after the patient is confirmed eligible to the study, the treatment(s) will be switched immediately into the study's regimens. Clinical and laboratory examinations to evaluate the investigational drug's efficacy will be performed at baseline, day 4, and day 8 of treatment (end of study); while safety examinations will be performed at baseline and end of study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
DLBS1033, acute ischemic stroke, MRS, mNIHSS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered orally, 3 x 1 tablet daily, for 8 days of study period
Arm Title
DLBS1033 Group
Arm Type
Experimental
Arm Description
DLBS1033 will be administered orally, 3 x 1 tablet daily, for 8 days of study period
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo of DLBS1033
Intervention Description
Placebo of DLBS1033 will be given in addition to the standard therapy consisting of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, vitamin B complex 1 x 1 tablet daily, and citicholine injection 250 mg/2 mL twice daily
Intervention Type
Drug
Intervention Name(s)
DLBS1033
Other Intervention Name(s)
Disolf
Intervention Description
DLBS1033 enteric-coated tablets will be given in addition to the standard therapy consisting of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, vitamin B complex 1 x 1 tablet daily, and citicholine injection 250 mg/2 mL twice daily
Primary Outcome Measure Information:
Title
Improvement in mNIHSS score
Description
Change in functional outcomes as measured by The Modified National Institute of Health Stroke Scale (mNIHSS) from its baseline value
Time Frame
7 days after treatment initiation
Secondary Outcome Measure Information:
Title
Improvement in MRS
Description
Change in functional outcomes as measured by Modified Rankin Scale (MRS) from its baseline value
Time Frame
7 days after treatment initiation
Title
Improvement in fibrinogen level
Description
Change in haemostatic parameter as measured by fibrinogen level from its baseline value
Time Frame
7 days after treatment initiation
Title
Improvement in d-dimer level
Description
Change in haemostatic parameter as measured by d-dimer level from its baseline value
Time Frame
7 days after treatment initiation
Title
Liver function
Description
Liver function measured will be: serum AST, ALT, G-GT, total bilirubin
Time Frame
7 days after treatment initiation
Title
Renal function
Description
Renal function measured will be serum creatinine
Time Frame
7 days after treatment initiation
Title
Routine hematology
Description
Routine hematology measured will be: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count
Time Frame
7 days after treatment initiation
Title
Hemostasis parameters
Description
Hemostasis parameters measured will be: PT and aPTT
Time Frame
7 days after treatment initiation
Title
Adverse events
Description
Adverse events, including bleeding events, will be observed and carefully evaluated during the expected average of 7 days of study treatment.
Time Frame
7 days after treatment initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects with age of 18-75 years . Has been diagnosed with acute ischemic stroke clinically confirmed by CT scan. Modified National Institutes of Health Stroke Scale (mNIHSS) score >= 5. Patients present at hospital and receiving first dose of study medication within 72 hours after the onset of the stroke symptoms. Able to take oral medication. Exclusion Criteria: For females of childbearing potential: pregnancy and lactation period. History of or current hemorrhagic stroke (within the last 3 months). Transient ischemic stroke (TIA). Patients with seizure at the onset of stroke. History of serious head injury within the last 3 months. History of major surgery within the last 3 months. Serious cardiovascular conditions, such as myocardial infarction, CHF grade III and IV (NYHA classification), aorta dissection, and atrial fibrillation within the last 6 months. Presence of severe renal or hepatic dysfunction Presence of acute or chronic infections. Thrombocytopenia (thrombocytes level < 150.000/ul). Patients with higher risks of bleeding. Uncontrolled hypertension (systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg). Random plasma glucose >= 200 mg/dL. Current or regular use of oral anticoagulants, antiplatelets other than study medication, and herbal medicines. Hypersensitive to the investigational product(s).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tut W Handayani, Sp.S, MD
Organizational Affiliation
RSUD R. Syamsudin, SH
Official's Role
Principal Investigator
Facility Information:
Facility Name
RSUD R. Syamsudin, SH
City
Sukabumi
State/Province
West Java
ZIP/Postal Code
43113
Country
Indonesia

12. IPD Sharing Statement

Learn more about this trial

DLBS1033 for the Treatment of Acute Ischemic Stroke

We'll reach out to this number within 24 hrs