MLC901 in Moderate Traumatic Brain Injury
- Conditions
- Moderate Traumatic Brain Injury
- Interventions
- Dietary Supplement: MLC901Genetic: Placebo
- Registration Number
- NCT04766281
- Lead Sponsor
- University of the Philippines
- Brief Summary
This study wants to evaluate whether MLC901 will help improve the condition of adult patients with moderate traumatic brain injury.
- Detailed Description
This is a double blind placebo controlled randomized trial to determine whether giving MLC901 for 6 months will improve the outcomes in a adult patients with moderate traumatic brain injury.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Age 18-65 years
- 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
- Penetrating HI
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MLC901 (NeuroAiD II) MLC901 This consists of extracts from 9 herbal components in a dark blue/light blue capsule Placebo Placebo This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule
- Primary Outcome Measures
Name Time Method GOS-E at 6 months 18 months This is the most widely used TBI outcome measure with the extended version ranging from 0 (dead) to 8 (full recovery)
- Secondary Outcome Measures
Name Time Method Safety until 9 months: adverse events 18 months Safety is assessed by checking for the occurence of adverse events
Glasgow Coma Scale (GCS) at baseline, 1, 3, 6 & 9 months 18 months This is a widely used clinical scale to assess the depth and duration of impaired consciousness and coma by measuring motor responsiveness, verbal performance and eye opening. The score ranges from 3 to 15.
Frontal Assessment Battery at 1,3,6 & 9 monts 18 months This battery of tests is used to assess frontal lobe dysfunction, consisting of the following sub tests: conceptualisation, mental flexibility, motor programming, sensitivity to interference, inhibitory control and environmental autonomy.Total scor is from a maximum of 18, with higher scores indicating better performance.
EQ-5D at 1,3,6 & 9 months (EuroQol Group) 18 months This instrument describes the health status of respondents in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The score ranges from 0-100, with higher scores for higher health related quality of life.
Mortality at 6 months 18 months The number of patients who died in each arm at 6 months
Glasgow Outcome Scale Extended (GOS-E) at baseline, 1,3 & 9 months 18 months This clinical scale is the most widely used outcome measure after TBI, with the extended version scoring from 0 (dead) to full recovery (8).
Montreal Cognitive Assessment Filipino Version (MoCA-P) at 1,3,6 & 9 months 18 months This is an adaptation of the MoCA to the Philippine setting, used in the detection of mild cognitive impairment. The scores range between 0-10, with a score of 26 or over considered to be normal.
RiverMead Postconcussion Symptome Questionnaire Score at 1,3,6 & 9 months 18 months This is a 10 item questionnaire mainly used for patients with mild to moderate TBI. This is a 16 item questionnaire, scored on a 5 point Liberty scale ranging from 0 (not experienced at all) to 4 ( a severe problem).
Compliance until 6 months 18 months Compliance is documented by the number of medications taken at set intervals during follow up
Cerebral swelling at baseline, 1 & 2 weeks 18 months Cerebral swelling is assessed by CT-scan
Barthel Index (BI) at 1,3,6 & 9 months 18 months This scale is used to assess functional disability by quantifying patient performance in 10 activities of daily living. The score ranges from 0 (totally dependent) to 100 (fully independent).
Hospital Anxiety and Depression Scale at 1,3,6 & 9 months 18 months This scale is used to measure levels of anxiety and depression, ranging from 0 to 21,with normal score of 0-7, mild 8-10, moderate 11-14 and severe 15-21.
Trial Locations
- Locations (3)
Philippine General Hospital
🇵ðŸ‡Manila, Philippines
Mariano Marcos Memorial Hospital and Medical Center
🇵ðŸ‡Batac, Ilocos Norte, Philippines
Northern Mindanao Medical Center
🇵ðŸ‡Cagayan De Oro, Misamis Oriental, Philippines