Ignite Creation Date:
2024-05-06 @ 2:48 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02133521
Status:
TERMINATED
Last Update Posted:
2023-12-12
First Post:
2014-05-07
Brief Title:
DLBS1033 for Acute Ischemic Stroke Patients
Sponsor:
Dexa Medica Group
Organization:
Dexa Medica Group
Study Overview
Official Title:
Addition of DLBS1033 to Standard Therapy for Acute Ischemic Stroke Patients
Status:
TERMINATED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADDLIST
Brief 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
Detailed Description:
Subjects in this study will be screened consecutively and eligible subjects will be randomized into two groups and receive the investigational drug DLBS1033 at a dose of 490 mg three times daily or its placebo in addition to standard therapy for 28-days course of therapy Standard therapy used in this study will consist of aspirin 80 mg simvastatin 20 mg and vitamin B complex
After hospital admission and diagnosis patient will be handled as per acute ischemic stroke management in each study site Right after the patient is confirmed eligible to the study the treatments will be switched immediately into the study treatments Clinical and laboratory examinations to evaluate the investigational drugs efficacy will be performed at baseline and 3 714 and 28 days after study medication initiation while safety examinations will be performed at the same time point but 3 and 14 days after study medication initiation
After hospital admission and diagnosis patient will be handled as per acute ischemic stroke management in each study site Right after the patient is confirmed eligible to the study the treatments will be switched immediately into the study treatments Clinical and laboratory examinations to evaluate the investigational drugs efficacy will be performed at baseline and 3 714 and 28 days after study medication initiation while safety examinations will be performed at the same time point but 3 and 14 days after study medication initiation
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