drugset / Trial / NCT02133521

DLBS1033 for Acute Ischemic Stroke Patients

NCT02133521 ↗

Phase 2/3 Terminated 80 enrolled Dexa Medica Group
RandomizedParallel-groupQuadruple-blindTreatment

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. It is hypothesized that the improvement in functional outcomes as measured by NIHSS and BI as well as the improvement in haemostatic parameters as measured by thrombocyte aggregation test (TAT), fibrinogen, and d-dimer in DLBS group will be significantly greater than those in the control group.

Timeline

Start
2014-11-11
Primary completion
2023-02-21
Completion
2023-04-21

Outcome

Outcome not reported

Stopped (Enrollment): “Very low recruitment rate. The Study Sites classified as tertiary referral hospital. Therefore, patients being referred to the site are mostly those with comorbidities included in the exclusion criteria.”

Drugs

EvaluationDrugModalityDoseRoute
Subject DLBS1033 Protein / enzyme biologic 490 mg —

Indications