This is a randomized, controlled, open-label study of MLC901 (NeuroAiD™ II) in patients with mild to moderate ischemic stroke. Eligible participants will be randomized in a 1:1 ratio to receive MLC901 in combination with standard treatment or standard treatment alone for 12 weeks.
A total of 80 patients will be included, with approximately 40 patients randomized to each treatment group. Group 1: Participants will receive MLC901 (400 mg, 2 capsules per dose, 3 times daily) in combination with standard treatment according to the protocol. Group 2: Participants will receive standard treatment according to the protocol. The treatment period will last for 12 weeks. An optional follow-up visit at Week 24 may be conducted to assess the durability of the treatment effect. Efficacy assessments will include the EuroQol 5-Dimension 5-Level (EQ-5D-5L), EuroQol Visual Analogue Scale (EQ-VAS), Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM-1.4), Fugl-Meyer Assessment (FMA), National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), muscle strength assessment, and MRI-based assessment of cerebral infarct volume. Safety will be assessed throughout the study through the monitoring of adverse events and hemorrhagic complications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
MLC901 (NeuroAiD™ II) 400 mg hard capsules, administered orally at a dose of 2 capsules three times daily for 12 weeks, in combination with standard treatment according to the protocol.
Participants will receive standard treatment for acute ischemic stroke according to the study protocol for 12 weeks
Traditional Medicine Institute
Ho Chi Minh City, Vietnam
RECRUITINGEuroQol 5-Dimension 5-Level (EQ-5D-5L)
The EQ-5D-5L is a patient-reported measure of health-related quality of life covering five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of response.
Time frame: Baseline, Day 7 and Day 14
EuroQol Visual Analogue Scale (EQ-VAS)
The EQ-VAS records the participant's self-rated health on a vertical visual analogue scale ranging from 0 to 100, where 0 represents the worst health the participant can imagine and 100 represents the best health the participant can imagine.
Time frame: Baseline, Day 7 and Day 14
Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM-1.4)
The TSQM-1.4 is a patient-reported questionnaire used to assess treatment satisfaction across the domains of effectiveness, side effects, convenience, and global satisfaction.
Time frame: Baseline, Day 7 and Day 14
Adverse Events
Frequency, incidence rate, and severity of adverse events during the study period.
Time frame: From baseline through Week 12, and at the optional Week 24 follow-up visit.
Hemorrhagic Complications
Presence or absence of hemorrhagic complications during the study period.
Time frame: From baseline through Week 12, and at the optional Week 24 follow-up visit.
Modified Rankin Scale (mRS)
The modified Rankin Scale (mRS) is used to assess the degree of disability or dependence in daily activities following stroke. Scores range from 0 (no symptoms) to 6 (death).
Time frame: Baseline, Week 4 and Week 12
Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation, and joint functioning following stroke.
Time frame: Baseline, Day 14, Week 4 and Week 12
National Institutes of Health Stroke Scale (NIHSS)
The National Institutes of Health Stroke Scale (NIHSS) is used to assess neurological impairment following stroke. Scores range from 0 to 42, with higher scores indicating greater neurological impairment.
Time frame: Baseline, Day 14 and Week 12
Maximum Muscle Strength
Maximum muscle strength will be assessed using the Mobie fixed-belt hand-held dynamometer.
Time frame: Baseline, Day 7, Day 14, Day 21, Week 4, Week 8 and Week 12
Cerebral Infarct Volume on Magnetic Resonance Imaging (MRI)
Change in cerebral infarct volume from baseline will be assessed using magnetic resonance imaging (MRI).
Time frame: Baseline and Week 12 (±7 days)
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