MLC901 in Moderate Traumatic Brain Injury

University of the Philippines120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Moderate Traumatic Brain Injury

Interventions

MLC901DIETARY_SUPPLEMENT

This consists of extracts from 9 herbal components in a dark blue/light blue capsule

PlaceboGENETIC

This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (3)

Mariano Marcos Memorial Hospital and Medical Center

Batac, Ilocos Norte, Philippines

RECRUITING

Northern Mindanao Medical Center

Cagayan de Oro, Misamis Oriental, Philippines

RECRUITING

Philippine General Hospital

Manila, Philippines

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 18 months

Secondary Outcomes

Mortality at 6 months

The number of patients who died in each arm at 6 months

Time frame: 18 months

Cerebral swelling at baseline, 1 & 2 weeks

Cerebral swelling is assessed by CT-scan

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Central Contacts

Annabell E Chua, MD

CONTACT

+632-85242338 aechua@up.edu.ph

Data from ClinicalTrials.gov

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