Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

Completed

Phase 3 Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • Clopidogrel (Plavix┬«)Drug
    Other Names: Plavix
    Intervention Desc: 1 tablet of clopidogrel 75 mg once daily, after meal
    ARM 1: Kind: Experimental
    Label: Treatment III
    Description: 1 tablet of clopidogrel 75 mg once daily, after meal
  • Aspirin Drug
    Other Names: clopidogrel; combination aspirin-dipyridamole
    Intervention Desc: 1 tablet of aspirin 80 mg once daily, after meal
    ARM 1: Kind: Experimental
    Label: Treatment II
    Description: 1 tablet of aspirin 80 mg once daily, after meal
  • DLBS1033 Drug
    Other Names: Disolf
    Intervention Desc: 1 tablet of DLBS1033 490 mg thrice daily, after meal
    ARM 1: Kind: Experimental
    Label: Treatment I
    Description: 1 tablet of DLBS1033 490 mg thrice daily, after meal

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in INR value 3 Months No
Secondary Change in PT 3 Months No
Secondary Change in aPTT 3 Months No
Secondary Change in Gadjah Mada Stroke Scale 3 Months No
Secondary Change in Barthel Index 3 Months No

Sponsors