An open Clinical Pilot Study to Evaluate the Safety and Efficacy of Natto Kinaseas an Add-on Oral Fibrinolytic Agent Tolow Molecular Weight Heparin & Anti-plateletsin Acute Ischeamic Stroke

Objectives To evaluate the efficacy of oral NATTOKINASE (NK) in the prevention of stroke progression Death in patients of acute ischaemic stroke. To measure the incidence of adverse drug events with oral NK.
Method Prospective Multicenter Proof?of?concept Open Pilot Study
Results 5 patients showed favorable response according to NIHSS scale, 11 patients according to MRS scale and 8 patients according to BI scale on day 90. Thrombolysis related parameters such as bleeding time at day 7, Clotting time at day 2 and day 7, PT at day 7, APTT at day 2, D dimer at day 2 and day 7 are significant different(p<0.05). Increase PT, APTT and FDP are suggestive of good fibrinolytic action of NK. Failure of this to translate in to obvious clinical bleeding is suggestive of a good balanced fibrinolytic effect. The overall efficacy data suggests that NK, in none of the patients studied, led to a progression of the underlying stroke, although the time taken for reversal of stroke did vary across the subjects chosen. A beneficial effect may be demonstrated, however a further larger comparative study will be necessary under similar conditions.