Amount: US$

The clinical studies conducted in China, were double-blind controlled clinical trials where NeuroAiD efficacy was assessed versus another Traditional Chinese Medicine (TCM) proven to be superior to Citicoline in separate trials.

606 ischemic stroke patients at a late restoration stage (14 days) were enrolled in these studies: 201 patients for phase II and 405 patients for phase III.

Efficacy was assessed after one month of treatment. As per most of the Western stroke trials, they consisted of measuring functional outcomes and neurological deficit with standard scales.

During Chinese Clinical studies, stroke patients have undergone several physical check-up to assess the safety of NeuroAiD such as blood, hepatic, cardiac or renal standard testing. No abnormal changes were observed. Two additional clinical studies have also confirmed that NeuroAiD given alone or in combination with aspirine does not increase the bleeding or thrombotic risk.

Functional outcome measures the ability to live independently and to carry daily activities. This is the most important criteria to measure recovery of a patient after stroke.

If we look at a very stringent definition of recovery, i.e. reaching "able to take care of oneself and speak freely", the Chinese studies have shown that patients receiving NeuroAiD have 2.11 times more chances than control patient to reach this stage. The odds ratio(OR) is 2.11 with a confidence interval of 95% [1.12 - 3.98]. Based on the stringent definition of complete responder as reaching a Comprehensive Functions score equal to 0, NeuroAiD records 12.5% responder versus 6.3% in the control group (6.2% of absolute difference).

If we look at an enlarged definition of recovery i.e. reaching at least "able to live independently but incomplete function", Chinese studies have shown that patients receiving NeuroAiD have 1.29 times more chances than patients in the control group to reach this stage. The odds ratio(OR) is 1.29 with a confidence interval of 95% [0.92-1.82]. Based on a enlarged definition of responders as patients reaching a Comprehensive Functions score = 2, which is becoming the standard in western stroke trial methodology ("reaching a Rankin of 1 or 2"): NeuroAiD records 45.8% of responders versus 39.5% in the control group (6.3 % of absolute difference).

 

Neurological deficit measures the level of motor and cognitive disability by assessing the patient improvements on language, facial paralysis, eye symptoms, upper limb paralysis, lower limb paralysis, finger paralysis and toe paralysis.

Patients receiving NeuroAiD have 1.95 times more chances to reach a low to mild status than patients in the control group. The OR with a 95% confidence interval for patients reaching a low a mild neurological deficit severity is 1.95 [1.37-2.79].

Compared with the control, NeuroAiD significantly improved the neurological deficit recovery. Graph below shows superiority of NeuroAiD in improving the initial neurological deficit resulting from the stroke onset as 77% of patients in the treatment group reached at least a common level of disability compared to 57% in the control group.

Overall reduction of neurological deficits

Neurological deficit score reduction
Post treatment distribution of patient in %

The neurological deficit score = sum of deficit assessed on 7 criteria (similar to the NIHSS, 80% motor). The higher the score, the worse the deficits.

Patients receiving NeuroAiD have 1.95 times more chances to reduce their neurological deficit of at least 50% than patients receiving control.

The comparison of the distribution of the neurological deficit scores imporvement in the two groups is highly significant with a P-value was 0.014 in favor to NeuroAiD. Odds Ratio of NeuroAiD/Buchang (95% CI): 1.659 (1.224 to 2.247)

Analysis of reduction of neurological deficits on individual neurological deficit

Upper limb paralysis

Finger paralysis

Lower limb paralysis

Toe paralysis

Language paralysis

Facial paralysis