I. Animal Studies

The published results describe a significant neuroprotective effect of NeuroAiD™ against an ischemic insult when given prior and/or after injury. It shows that NeuroAiD™ supports neuroplasticity, increases neurogenesis, increases neurites outgrowth and synaptogenesis, provides a better environment for post stroke recovery and decreases neurological impairments.

MLC901, a traditional Chinese medicine protects the brain against global ischemia. Neuropharmacology. 2011

The results of this clinical study led on rodents describe a significant neuroprotective effect of MLC901 on hippocampal CA1 region against global ischemia. It shows that thanks to Akt protein, MLC901 prevents necrosis and apoptotic cell death induced by global ischemia, enhances neurogenesis and improves functional recovery. Thus, MLC901 could be a novel therapeutic strategy in treating not only cognitive and motor deficits caused by global ischemia, but also neurological deficits caused by cardiac arrest and other situations that deprive brain of oxygen and glucose.

II. Ischemic Stroke

NeuroAiD™ (Danqi Piantan Jiaonang), a traditional Chinese medicine, in post stroke recovery. Stroke. 2009

This reports deals with clinical trials led on 605 patients recruited between 2 weeks and 6 months after their stroke (initial stroke trials in China). The results show that patients on NeuroAiD™ have 2.4 times more chances to achieve independence after 1 month of treatment, and have a 25% higher recovery in the motor impairments.

Safety and efficacy of MLC601 in Iranian patients after stroke: a double-blind, placebo-controlled clinical trial. Stroke Research and Treatment. 2011

This study, led on 150 Iranian patients with a recent ischemic stroke, shows that MLC601 not only improves motor recovery, but also is safe on top of standard ischemic stroke medication especially in severe and moderate cases. In fact, patients who received MLC601 showed significantly better motor recovery than placebo group after 4, 8 and 12 weeks. The improvement was mostly manifested after first month and developed more during 12 weeks. Moreover, good tolerability to treatment was shown and adverse events were mild and transient.

This double-blind placebo-controlled randomized study was led on 80 patients. Among them, 40 received 4 capsules of NeuroAiD™ 3 times a day for 3 months and 40 others received placebo. The subjects were recruited at Ahvaz Golestan Hospital in Iran from April 2009 to March 2010. This study shows that MLC601 increases cerebral blood flow velocity in post brain infarct subjects. Results show that the increase in cerebral blood flow velocity is significantly higher in MLC601 group than in control group. Eventually, patients cured with MLC601 recorded a significant improvement in their daily activities.

A double-blind, placebo-controlled, randomized phase II pilot study to investigate the potential efficacy of the traditional Chinese medicine NeuroAiD (MLC601) in enhancing recovery after stroke (TIERS). Cerebrovascular Diseases 2009.

The aim of this phase II double-blind placebo controlled study was to investigate the efficacy of NeuroAiD on motor recovery in ischemic stroke patients using rehabilitation endpoints in order to provide predictive information for further larger trials. In this clinical trial, 20 patients within 1 month post-stroke received 4 capsules of NeuroAiD 3 times a day for 4 weeks and 20 other patients received placebo. While no statistical significance was detected for all primary and secondary endpoints due to the small sample size, subgroup analysis show trends for better outcome with NeurAiD for more severe strokes, posterior strokes, and strokes with potential for recovery at 8 weeks.

NeuroAiD (MLC601) versus piracetam in the recovery of post-infarct homonymous hemianopsia. Neural Regeneration Research 2011.

In the clinic, the natural recovery rate of homonymous hemianopsia caused by occipital lobe infarction is low. This prospective study compared the effects of NeuroAiD (MLC 601) versus piracetam in improving visual field defects in 40 patients matched for age and sex within 1 week of PCA infarction with pure homonymous hemianopsia. After 3 months of treatment, the findings suggest that MLC601 is superior to piracetam for reducing quantitative visual field defects in homonymous hemianopsia patients.

NeuroAiD in Stroke Recovery. European Neurology 2008.

This case series report deals with 10 patients who received NeuroAiD after an ischemic stroke as confirmed on brain imaging (MRI). Conducted in an outpatient private clinic in Mount Alvernia Hospital in Singapore, the report suggests that NeuroAiD can be considered as an add-on treatment to other medications including anti-platelet, warfarin, lipid-lowering, anti-hypertensive, anti-diabetic, and antidepressant medications.

III. Hemorrhagic Stroke and Traumatic Brain Injury

Case report on the use of MLC601 (NeuroAiD) in neurosurgical pathologies. Poster WSC Seoul. 2010.

This case series report of 20 patients treated with MLC601 in the Neurosurgery division of National University Hospital in Singapore. All patients received 4 capsules of MLC601 3 times a day for 3 months started within 3 months of onset of brain injury or stroke. All patients reported some improvements and good tolerance for the drug. Three cases (head injury, hemorrhagic stroke from AVM, and brain abscess) with remarkable outcomes were presented, illustrating how it may not be unreasonable to prescribe MLC601 to selected patients with difficult neurosurgical pathology in the hope that the neurological function outcome would improve.

IV. Safety

Safety Profile of MLC601 (NeuroAiD) in acute ischemic stroke patients: a Singaporean substudy of the Chinese medicine NeuroAiD efficacy on stroke recovery study. Cerebrovascular Diseases 2010.

This study on 114 patients with acute ischemic stroke randomized within 48 hours of onset shows that serious adverse events (SAEs) were similar between the group treated with placebo and the group treated with MLC601. The SAEs reported were those commonly seen in stroke patients. There were neither statistically or clinically significant differences between treatment groups in biochemical, haematological, or electrocardiogram tests at 3 months, nor any statistically or clinically significant differences in the absolute and relative changes of the various parameters between baseline and 3 months. Thus, MLC601 is safe for patients with acute stroke receiving a 3-month treatment.

NeuroAiD does not modify hemostasis, hematology, and biochemistry in normal subjects and stroke patients. Cerebrovascular Diseases 2008.

NeuroAiD does not significantly affect hematological, hemostatic, and biochemical parameters in normal and stroke patients. Clinical parameters and expected effects of aspirin are not altered by co-administration of the drug even when started and maintained at the early stage of acute stroke.

V. Clinical Trial

A double-blind, placebo-controlled, randomized, multicenter study to investigate Chinese medicine NeuroAiD efficacy on stroke recovery (CHIMES Study). International Journal of Stroke 2009.

NeuroAiD does not significantly affect hematological, hemostatic, and biochemical parameters in normal and stroke patients. Clinical parameters and expected effects of aspirin are not altered by co-administration of the drug even when started and maintained at the early stage of acute stroke.