Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01790997
Study type	Interventional
Source	Dexa Medica Group
Contact
Status	Completed
Phase	Phase 3
Start date	May 2012
Completion date	December 2013

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06113848` - Adjunctive Use of Intra-Arterial TNK and Albumin Following Thrombectomy	Phase 3
Completed	`NCT04069546` - The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency	N/A
Active, not recruiting	`NCT05700097` - Dengzhanxixin Injection for Acute Ischemic Stroke Receiving Reperfusion Therapy	Phase 2
Recruiting	`NCT06058130` - Combination of Antiplatelet and Anticoagulation for AIS Patients Witn Concomitant NVAF and Extracranial/Intracranial Artery Stenosis	N/A
Recruiting	`NCT04415164` - Evaluation of Xueshuantong in Patients With AcutE IschemiC STroke	Phase 4
Recruiting	`NCT05363397` - Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke	Phase 2
Completed	`NCT05429658` - Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System	N/A
Recruiting	`NCT05390580` - Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct	N/A
Enrolling by invitation	`NCT05515393` - A Study of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke	Phase 2
Active, not recruiting	`NCT05070260` - ACTISAVE: ACuTe Ischemic Stroke Study Evaluating Glenzocimab Used as Add-on Therapy Versus placEbo	Phase 2/Phase 3
Terminated	`NCT05547412` - Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke
Completed	`NCT03366818` - New Stent Retriever, VERSI System for AIS	N/A
Not yet recruiting	`NCT05293080` - Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE	Phase 3
Not yet recruiting	`NCT06437431` - Glenzocimab in Anterior Stroke With Large Ischemic Core Eligible for Endovascular Therapy	Phase 2/Phase 3
Not yet recruiting	`NCT06040476` - Human Umbilical Cord Blood Infusion in Patients With Acute Ischemic Stroke (AIS)	Phase 2
Completed	`NCT02223273` - Brazilian Intervention to Increase Evidence Usage in Practice - Stroke (BRIDGE-Stroke)	N/A
Completed	`NCT02586233` - Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke	Phase 1/Phase 2
Not yet recruiting	`NCT01594190` - Physical Activity Immediately After Acute Cerebral Ischemia	N/A
Terminated	`NCT01694381` - Research Into the Effect of a Clot-dissolving Agent and Its Inhibitor	Early Phase 1
Completed	`NCT01120301` - Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3)	Phase 3