DLBS1033 for the Treatment of Acute Ischemic Stroke

NCT ID: NCT02362984

Last Updated: 2017-05-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-04-30

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Control Group

Placebo will be administered orally, 3 x 1 tablet daily, for 8 days of study period

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo of DLBS1033 will be given in addition to the standard therapy consisting of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, vitamin B complex 1 x 1 tablet daily, and citicholine injection 250 mg/2 mL twice daily

DLBS1033 Group

DLBS1033 will be administered orally, 3 x 1 tablet daily, for 8 days of study period

Group Type: EXPERIMENTAL

DLBS1033

Intervention Type: DRUG

DLBS1033 enteric-coated tablets will be given in addition to the standard therapy consisting of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, vitamin B complex 1 x 1 tablet daily, and citicholine injection 250 mg/2 mL twice daily

Interventions

Placebo

Placebo of DLBS1033 will be given in addition to the standard therapy consisting of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, vitamin B complex 1 x 1 tablet daily, and citicholine injection 250 mg/2 mL twice daily

Intervention Type: DRUG

DLBS1033

DLBS1033 enteric-coated tablets will be given in addition to the standard therapy consisting of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, vitamin B complex 1 x 1 tablet daily, and citicholine injection 250 mg/2 mL twice daily

Intervention Type: DRUG

Other Intervention Names

Placebo of DLBS1033; Disolf

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dexa Medica Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tut W Handayani, Sp.S, MD

Role: PRINCIPAL_INVESTIGATOR

RSUD R. Syamsudin, SH

Locations

RSUD R. Syamsudin, SH

Sukabumi, West Java, Indonesia

Countries

Indonesia

Other Identifiers

DLBS1033-0614

Identifier Type: -

Identifier Source: org_study_id