DLBS1033 for the Treatment of Acute Ischemic Stroke

Terminated

Phase 3 Results N/A

Trial Description

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.

Trial Stopped: Major technical hindrance in recruitment.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Control Group
    Description: Placebo will be administered orally, 3 x 1 tablet daily, for 8 days of study period
  • DLBS1033 Drug
    Other Names: Disolf
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: DLBS1033 Group
    Description: DLBS1033 will be administered orally, 3 x 1 tablet daily, for 8 days of study period

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Improvement rate in MRS 7 days after treatment No
Secondary Improvement in mNIHSS 3 and 7 days after treatment No
Secondary Improvement in fibrinogen level 7 days after treatment No
Secondary Improvement in d-dimer level 7 days after treatment No
Secondary Liver function 7 days after treatment Yes
Secondary Renal function 7 days after treatment Yes
Secondary Routine hematology 7 days after treatment Yes
Secondary Hemostasis parameters 7 days after treatment Yes
Secondary Adverse events Along the course of the study Yes
Primary Improvement in mNIHSS score 7 days after treatment initiation No
Secondary Improvement in MRS 7 days after treatment initiation No

Sponsors