The role of DLBS1033 in the management of acute ischemic stroke patients: study protocol for a randomized controlled study
Tahapan Penelitian : Initial
Sponsor:
Duta Wacana Christian University School of Medicine, Yogyakarta, Indonesia
Mitra Pelaksana:
Bethesda Hospital, Yogyakarta, Indonesia
No Registry
INA-53EA9LH
Tanggal Input Registry : 02-12-2019
Tracking Information | |
---|---|
Tanggal Antisipasi Studi | 30-12-2019 |
Outcome Primer | Modified Rankin Scale (mRS) measured at first day/onset, at hospital discharge, and 30 days after onset. |
Outcome Skunder | 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 |
Descriptive Information | |
Judul Penelitian Popular | The role of DLBS1033 in the management of acute ischemic stroke patients: study protocol for a randomized controlled study |
Judul Penelitian Ilmiah | The role of DLBS1033 in the management of acute ischemic stroke patients: study protocol for a randomized controlled study |
Jenis Penelitian | Bioequivalence study |
Intervensi | 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. |
Jumlah Subyek Penelitian | 180 |
Recruitment Information | |
Eligibility Criteria | 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. OnsetExclusion 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 |
Administrative Information | |
Nomor Persetujuan Etik | 1087/C.16/FK/2019 |
Nomor Persetujuan Material Transfer Agreement | |
Nomor Persetujuan Pelaksanaan Uji Klinik | |
Other Study ID Numbers | 03/PZ/XII/2019 |
Contact Person | dr. Rosa De Lima Renita Sanyasi |