Ignite Creation Date:
2024-05-06 @ 1:22 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01790997
Status:
COMPLETED
Last Update Posted:
2014-06-04
First Post:
2013-02-12
Brief Title:
Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke
Sponsor:
Dexa Medica Group
Organization:
Dexa Medica Group
Study Overview
Official Title:
The Role of DLBS1033 in Evaluating Bleeding Profile and Clinical Outcome in Patients With Acute Ischemic Stroke Comparison With Aspirin and Clopidogrel
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None