The role of DLBS1033 in the management of acute ischemic stroke patients: study protocol for a randomized controlled study

Tahapan Penelitian : Initial
Sponsor:
Mitra Pelaksana:
Bethesda Hospital, Yogyakarta, Indonesia
No Registry
INA-53EA9LH
Tanggal Input Registry : 02-12-2019

30-12-2019
Modified Rankin Scale (mRS) measured at first day/onset, at hospital discharge, and 30 days after onset.
The secondary outcome will be measured at first day/onset, at hospital discharge, and 30 days after onset. 1. Mental Mini State Examination (MMSE) 2. 5Q-5D-5L 3. NIHSS 4. Barthel index 5. Safety profile
 
The role of DLBS1033 in the management of acute ischemic stroke patients: study protocol for a randomized controlled study
The role of DLBS1033 in the management of acute ischemic stroke patients: study protocol for a randomized controlled study
Bioequivalence study
This is a randomized controlled open label trial. There will be 2 groups in this study, group 1 consists of subjects treated with DLBS1033 + standard therapy of ischemic stroke, whereas group 2 consists of subjects treated with placebo of DLBS1033 + standard therapy of ischemic stroke. DLBS1033 and placebo of DLBS1033 will be given 2 tablets three times per day for 30 days.
180
 

Inclusion Criteria:

Inclusion criteria: 1. Male or female 2. Adult (age > 18 years) 3. Mild to moderate ischemic stroke based on Glasgow Coma Scale (GCS) fully alert and National Institutes of Health Stroke Scale (NIHSS) 4. Onset

Exclusion Criteria:

Exclusion criteria: 1. Not willing to join the study 2. Subjects with a known hypersensitivity to DLBS1033. 3. Participation in other clinical trial for the last 1 month 4. Incompetent to give a consent and answer the questionnaires
 
1087/C.16/FK/2019
03/PZ/XII/2019
dr. Rosa De Lima Renita Sanyasi