Clinical trial NCT02362984: DLBS1033 for the Treatment of Acute Ischemic Stroke
Official title: The Role of DLBS1033 in the Management of Acute Ischemic Stroke Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Ischemic Stroke
Keywords: DLBS1033
acute ischemic stroke
MRS
mNIHSS
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
First posted: 2015-02-13
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Improvement in mNIHSS score
timeFrame: 7 days after treatment initiation
Secondary outcomes:
measure: Improvement in MRS
timeFrame: 7 days after treatment initiation
measure: Improvement in fibrinogen level
timeFrame: 7 days after treatment initiation
measure: Improvement in d-dimer level
timeFrame: 7 days after treatment initiation
measure: Liver function
timeFrame: 7 days after treatment initiation
measure: Renal function
timeFrame: 7 days after treatment initiation
measure: Routine hematology
timeFrame: 7 days after treatment initiation
measure: Hemostasis parameters
timeFrame: 7 days after treatment initiation
measure: Adverse events
timeFrame: 7 days after treatment initiation
Other outcomes:
Locations:
city: Sukabumi
country: Indonesia
facility: RSUD R. Syamsudin, SH
state: West Java
Study officials:
affiliation: RSUD R. Syamsudin, SH
name: Tut W Handayani, Sp.S, MD
role: PRINCIPAL_INVESTIGATOR
References: