DLBS1033 for the Treatment of Acute Ischemic Stroke

Dexa Medica

Status and phase

Terminated

Phase 3

Conditions

Acute Ischemic Stroke

Treatments

Drug: Placebo

Drug: DLBS1033

Study type

Interventional

Funder types

Industry

Identifiers

NCT02362984

DLBS1033-0614

Details and patient eligibility

About

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.

Full description

Patients included into the study will be randomized into two groups and receive either standard therapy alone (as control group) or standard therapy plus DLBS1033 at a dose of 490 mg three times daily (as DLBS1033 group). Standard therapy used in the study will consist of: aspirin 80 mg, simvastatin 20 mg, vitamin B complex, and citicholine 250 mg/2 mL twice daily.

After hospital admission and diagnosis, patient will be handled according to the standard management for acute ischemic stroke applicable in the hospital. Right after the patient is confirmed eligible to the study, the treatment(s) will be switched immediately into the study's regimens. Clinical and laboratory examinations to evaluate the investigational drug's efficacy will be performed at baseline, day 4, and day 8 of treatment (end of study); while safety examinations will be performed at baseline and end of study.

Enrollment

9 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female subjects with age of 18-75 years .
Has been diagnosed with acute ischemic stroke clinically confirmed by CT scan.
Modified National Institutes of Health Stroke Scale (mNIHSS) score >= 5.
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 or current hemorrhagic stroke (within the last 3 months).
Transient ischemic stroke (TIA).
Patients with seizure at the onset of stroke.
History of serious head injury within the last 3 months.
History of major surgery within the last 3 months.
Serious cardiovascular conditions, such as myocardial infarction, CHF grade III and IV (NYHA classification), aorta dissection, and atrial fibrillation within the last 6 months.
Presence of severe renal or hepatic dysfunction
Presence of acute or chronic infections.
Thrombocytopenia (thrombocytes level < 150.000/ul).
Patients with higher risks of bleeding.
Uncontrolled hypertension (systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg).
Random plasma glucose >= 200 mg/dL.
Current or regular use of oral anticoagulants, antiplatelets other than study medication, and herbal medicines.
Hypersensitive to the investigational product(s).