Study Results
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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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2021-05-01
2024-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MLC901 (NeuroAiD II)
This consists of extracts from 9 herbal components in a dark blue/light blue capsule
MLC901
This consists of extracts from 9 herbal components in a dark blue/light blue capsule
Placebo
This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule
Placebo
This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule
Interventions
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MLC901
This consists of extracts from 9 herbal components in a dark blue/light blue capsule
Placebo
This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderate TBI
* Presenting at the study site within 7 days of injury
* Participant or his/her legal representative able to comply with the study protocol and willing to provide written informed consent
Exclusion Criteria
* Co-existing severe or unstable injury
* Physician's medical judgment that surgical intervention is likely within the next 48 hours
* Physician's medical judgment that participation is not in the participant's best interest
* Pre-injury mRS\>2
* Pregnancy
* Inability to take study drug orally or via NGT
* Participation in another investigational drug study
* Intake of nootropic drugs which are not standard TBI medications
18 Years
65 Years
ALL
No
Sponsors
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University of the Philippines
OTHER
Responsible Party
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Annabell Chua
Principal Investigator
Principal Investigators
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Annabell E Chua, MD
Role: PRINCIPAL_INVESTIGATOR
University of the Philippines Manila - Philippine General Hospital
Locations
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Mariano Marcos Memorial Hospital and Medical Center
Batac, Ilocos Norte, Philippines
Northern Mindanao Medical Center
Cagayan de Oro, Misamis Oriental, Philippines
Philippine General Hospital
Manila, , Philippines
Countries
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Central Contacts
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Facility Contacts
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References
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Chua AE, Yacapin VJ, Manalo GL 3rd, Ledesma LK. Protocol for Safety and Efficacy of MLC901 (NeuroAiD II) in Patients With Moderate Traumatic Brain Injury: A Randomized Double-Blind Placebo-Controlled Trial (ANDROMEDA). Neurosurgery. 2023 Oct 1;93(4):939-951. doi: 10.1227/neu.0000000000002512. Epub 2023 May 2.
Other Identifiers
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SJREB-2020-94
Identifier Type: -
Identifier Source: org_study_id
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