Stopped: 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.
Indonesia80 participantsStarted 2014-11-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed informed consent from the patients or patients' legally acceptable representatives (must be obtained before any trial related activities).
* Male or female subjects with age of \>18 years at Screening.
* Patients clinically diagnosed having acute ischemic stroke attack and confirmed by CT scan.
* Patients with cerebral infarction subtypes of PACI or LACI as classified by Bamford criteria.
* Patients with moderate condition based on National Institutes of Health Stroke Scale (NIHSS) score of 5-15.
* Patients present at hospital and receiving first dose of study medication within 72 hours after the onset of the stroke symptoms.
* Able to take oral medication.
Exclusion Criteria:
* For females of childbearing potential: pregnancy and lactation period.
* History of hemorrhagic stroke within the last 3 months.
* Patients with seizure at the onset of stroke or with regular medication for seizure/epilepsy.
* Current or regular use (within the last 1 month) of oral anticoagulants, antiplatelets other than study medication, and herbal medicines.
* Patients who have received tissue plasminogen activator (TPA) within 24 hours to Screening.
* History of serious head injury within the last 3 months.
* History of major surgery within the last 3 months.
* Recent serious cardiovascular conditions, such as myocardial infarction and heart atrial fibrillation as demonstrated by electrocardiography (ECG).
* History of congestive heart failure and aortic dissection…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
National Institutes of Health Stroke Scale (NIHSS)
Timeframe: 3, 7, 14, and 28 days after study medication
2
Barthel Index (BI)
Timeframe: 3, 7, 14, and 28 days after study medication