DLBS1033 for Acute Ischemic Stroke Patients

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.

Conditions

• Acute Ischemic Stroke
• Partial Anterior Circulation Infarct
• Lacunar Anterior Circulation Infarct

Interventions

DRUG

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

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

Sponsors & Collaborators

• Dexa Medica Group

  lead INDUSTRY

Principal Investigators

• Paulus Sugianto, Sp.S(K), Dr, MD · Indonesia's Neurologists Organization (Perdossi)

• Muh. Hamdan, Sp.S(K), MD · Neurology Department Dr. Soetomo Hospital

• Dodik Tugasworo, Sp.S(K), MD · Neurology Department Dr. Kariadi General Hospital

• Dian Cahyani, Sp.S, MD · Neurology Department Budhi Asih Hospital

• Diah H Soeryaningtias, Sp.S, MD · Neurology Department Haji Surabaya Hospital

• Gotot S PW, Sp.S, MD · Neurology Department Pasar Rebo Hospital

• Sugeng Wijayanto, Sp.S, MD · Neurology Department Sidoarjo Regional General Hospital

• Ika Y Margaretha, Sp.S, MD · Neurology Department Fatmawati Regional General Hospital

• Wiwin Sundawiyani, Sp.S, MD · Islam Jakarta Hospital (RSIJ) Cempaka Putih

• Rivan Danuaji, Sp.N(K), MD · Neurology Department Dr. Moewardi Hospital

• Hanindia R. Prabaningtyas, Sp.S(K), MD · Neurology Department Universitas Sebelas Maret (UNS) Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-11-11

Primary Completion

2023-02-21

Completion

2023-04-21

Countries

• Indonesia

Study Locations