Moderate Traumatic Brain Injury
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMLC901
This consists of extracts from 9 herbal components in a dark blue/light blue capsule
GENETICPlacebo
This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule
Sponsors
University of the Philippines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants are assigned to receive either MLC901 or placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Cerebral swelling at baseline, 1 & 2 weeks | 18 months | Cerebral swelling is assessed by CT-scan |
| 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). |
| 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. |
| 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. |
| 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. |
| Mortality at 6 months | 18 months | The number of patients who died in each arm at 6 months |
| 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. |
| 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. |
| Safety until 9 months: adverse events | 18 months | Safety is assessed by checking for the occurence of adverse events |
| Compliance until 6 months | 18 months | Compliance is documented by the number of medications taken at set intervals during follow up |
| 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). |
Countries
Philippines
Contacts
Primary ContactAnnabell E Chua, MD
Outcome results
None listed