NCT02362984

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

2.3 years

First QC Date

February 3, 2015

Last Update Submit

May 2, 2017

Conditions

Acute Ischemic Stroke

Keywords

DLBS1033acute ischemic strokeMRSmNIHSS

Outcome Measures

Primary Outcomes (1)

  • Improvement in mNIHSS score

    Change in functional outcomes as measured by The Modified National Institute of Health Stroke Scale (mNIHSS) from its baseline value

    7 days after treatment initiation

Secondary Outcomes (8)

  • Improvement in MRS

    7 days after treatment initiation

  • Improvement in fibrinogen level

    7 days after treatment initiation

  • Improvement in d-dimer level

    7 days after treatment initiation

  • Liver function

    7 days after treatment initiation

  • Renal function

    7 days after treatment initiation

  • +3 more secondary outcomes

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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

Drug: Placebo

DLBS1033 Group

EXPERIMENTAL

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

Drug: DLBS1033

Interventions

PlaceboDRUG

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

Also known as: Placebo of DLBS1033
Control Group
DLBS1033DRUG

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

Also known as: Disolf
DLBS1033 Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RSUD R. Syamsudin, SH

Sukabumi, West Java, 43113, Indonesia

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

DLBS 1033

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Tut W Handayani, Sp.S, MD

    RSUD R. Syamsudin, SH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 13, 2015

Study Start

October 1, 2014

Primary Completion

February 1, 2017

Study Completion

April 1, 2017

Last Updated

May 4, 2017

Record last verified: 2017-05

Locations

ID(1)