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DLBS1033 for Acute Ischemic Stroke Patients

NCT ID: NCT02133521

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-11

Study Completion Date

2023-04-21

Brief Summary

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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

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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 treatment(s) will be switched immediately into the study treatments. Clinical and laboratory examinations to evaluate the investigational drug's efficacy will be performed at baseline and 3, 7,14, 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.

Conditions

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Acute Ischemic Stroke Partial Anterior Circulation Infarct Lacunar Anterior Circulation Infarct

Keywords

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DLBS1033 Acute ischemic stroke NIHSS Barthel Index

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo 3 x 1 tablet, given everyday for 28 days of study period

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Investigational drug or placebo will be given in addition to the standard therapy, consists of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, and vitamin B complex 1 x 1 tablet

DLBS1033

DLBS1033 enteric-coated tablet 3 x 490 mg daily, given everyday for 28 days of study period

Group Type EXPERIMENTAL

DLBS1033

Intervention Type DRUG

Investigational drug or placebo will be given in addition to the standard therapy, consists of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, and vitamin B complex 1 x 1 tablet

Interventions

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DLBS1033

Investigational drug or placebo will be given in addition to the standard therapy, consists of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, and vitamin B complex 1 x 1 tablet

Intervention Type DRUG

Placebo

Investigational drug or placebo will be given in addition to the standard therapy, consists of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, and vitamin B complex 1 x 1 tablet

Intervention Type DRUG

Other Intervention Names

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Disolf

Eligibility Criteria

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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.
* Presence of severe renal and hepatic dysfunction, defined as serum creatinine level \> 3x upper limit of normal (ULN) or history of hemodialysis, and any of serum ALT, AST, Gamma-GT level of \> 3x ULN, respectively.
* Presence of acute SIRS.
* Presence of chronic infections.
* Patients with higher risks of bleeding.
* Subjects with uncontrolled hypertension (systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg).
* Subjects with random plasma glucose ≥180 mg/dL and HbA1c ≥ 7.0% at Screening.
* Known or suspected hypersensitivity to the trial product or related products.
* Participation in any other clinical studies within 30 days prior to screening.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dexa Medica Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paulus Sugianto, Sp.S(K), Dr, MD

Role: STUDY_CHAIR

Indonesia's Neurologists Organization (Perdossi)

Muh. Hamdan, Sp.S(K), MD

Role: PRINCIPAL_INVESTIGATOR

Neurology Department Dr. Soetomo Hospital

Dodik Tugasworo, Sp.S(K), MD

Role: STUDY_DIRECTOR

Neurology Department Dr. Kariadi General Hospital

Dian Cahyani, Sp.S, MD

Role: PRINCIPAL_INVESTIGATOR

Neurology Department Budhi Asih Hospital

Diah H Soeryaningtias, Sp.S, MD

Role: PRINCIPAL_INVESTIGATOR

Neurology Department Haji Surabaya Hospital

Gotot S PW, Sp.S, MD

Role: PRINCIPAL_INVESTIGATOR

Neurology Department Pasar Rebo Hospital

Sugeng Wijayanto, Sp.S, MD

Role: PRINCIPAL_INVESTIGATOR

Neurology Department Sidoarjo Regional General Hospital

Ika Y Margaretha, Sp.S, MD

Role: PRINCIPAL_INVESTIGATOR

Neurology Department Fatmawati Regional General Hospital

Wiwin Sundawiyani, Sp.S, MD

Role: PRINCIPAL_INVESTIGATOR

Islam Jakarta Hospital (RSIJ) Cempaka Putih

Rivan Danuaji, Sp.N(K), MD

Role: PRINCIPAL_INVESTIGATOR

Neurology Department Dr. Moewardi Hospital

Hanindia R. Prabaningtyas, Sp.S(K), MD

Role: PRINCIPAL_INVESTIGATOR

Neurology Department Universitas Sebelas Maret (UNS) Hospital

Locations

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Neurology Department, Dr. Kariadi General Hospital

Semarang, Central Java, Indonesia

Site Status

Universitas Sebelas Maret (UNS) Hospital

Sukoharjo, Central Java, Indonesia

Site Status

Dr. Moewardi Hospital

Surakarta, Central Java, Indonesia

Site Status

Neurology Department Fatmawati Regional General Hospital

Jakarta, DKI Jakarta, Indonesia

Site Status

Neurology Department, Budhi Asih Hospital

Jakarta, DKI Jakarta, Indonesia

Site Status

Neurology Department, Pasar Rebo Hospital

Jakarta, DKI Jakarta, Indonesia

Site Status

Neurology Department Islam Jakarta Hospital (RSIJ) Cempaka Putih

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Neurology Department Sidoarjo Regional General Hospital

Sidoarjo, East Java, Indonesia

Site Status

Neurology Department, Haji Surabaya Hospital

Surabaya, East Java, Indonesia

Site Status

Stroke/Cerebrobascular Division, Neurology Department, Dr. Soetomo Hospital

Surabaya, East Java, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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DLBS1033-0111

Identifier Type: -

Identifier Source: org_study_id