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This study wants to evaluate whether MLC901 will help improve the condition of adult patients with moderate traumatic brain injury.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MLC901 (NeuroAiD II) | Active Comparator | This consists of extracts from 9 herbal components in a dark blue/light blue capsule |
|
| Placebo | Placebo Comparator | This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MLC901 | Dietary Supplement | This consists of extracts from 9 herbal components in a dark blue/light blue capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| GOS-E at 6 months | This is the most widely used TBI outcome measure with the extended version ranging from 0 (dead) to 8 (full recovery) | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality at 6 months | The number of patients who died in each arm at 6 months | 18 months |
| Cerebral swelling at baseline, 1 & 2 weeks | Cerebral swelling is assessed by CT-scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annabell E Chua, MD | Contact | +632-85242338 | aechua@up.edu.ph |
| Name | Affiliation | Role |
|---|---|---|
| Annabell E Chua, MD | University of the Philippines Manila - Philippine General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mariano Marcos Memorial Hospital and Medical Center | Recruiting | Batac | Ilocos Norte | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37129384 | Derived | 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. |
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| ID | Term |
|---|---|
| C546417 | Neuroaid |
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Participants are assigned to receive either MLC901 or placebo
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| Placebo | Genetic | This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule |
|
| 18 months |
| Glasgow Outcome Scale Extended (GOS-E) at baseline, 1,3 & 9 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). | 18 months |
| Glasgow Coma Scale (GCS) at baseline, 1, 3, 6 & 9 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. | 18 months |
| Montreal Cognitive Assessment Filipino Version (MoCA-P) at 1,3,6 & 9 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. | 18 months |
| Frontal Assessment Battery at 1,3,6 & 9 monts | 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. | 18 months |
| RiverMead Postconcussion Symptome Questionnaire Score at 1,3,6 & 9 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). | 18 months |
| Barthel Index (BI) at 1,3,6 & 9 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). | 18 months |
| Hospital Anxiety and Depression Scale at 1,3,6 & 9 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. | 18 months |
| EQ-5D at 1,3,6 & 9 months (EuroQol Group) | 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. | 18 months |
| Safety until 9 months: adverse events | Safety is assessed by checking for the occurence of adverse events | 18 months |
| Compliance until 6 months | Compliance is documented by the number of medications taken at set intervals during follow up | 18 months |
| Northern Mindanao Medical Center | Recruiting | Cagayan de Oro | Misamis Oriental | 9000 | Philippines |
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| Philippine General Hospital | Recruiting | Manila | 1000 | Philippines |
|