Korean J Fam Pract. 2017; 7(2): 264-270  https://doi.org/10.21215/kjfp.2017.7.2.264
Efficacy and Safety of Ultra Nattokinase as a Fibrinolytic Agent: A Randomized, Double-Blind, Placebo-Controlled Study
Min-hee Kim, Kyung-min Kwon, Kyung-soo Kim*
Department of Family Medicine, Seoul St. Mary’s Hospital, School of Medicine, The Catholic University of Korea, Seoul, Korea
Kyung-soo Kim
Tel: +82-2-2258-2895, Fax: +82-2-2258-2907
E-mail: kskim@catholic.ac.kr
Received: June 3, 2016; Revised: August 19, 2016; Accepted: August 21, 2016; Published online: April 20, 2017.
© The Korean Academy of Family Medicine. All rights reserved.

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background: Natto is a traditional Japanese food prepared by fermentation of beans by Bacillus subtilis (natto bacteria). Recent studies have revealed that nattokinase from natto has fibrinolytic functions with a good safety profile. This study was designed to evaluate the safety and efficacy of Ultra Nattokinase to determine its suitability for application to Korean people.
Methods: Forty-three healthy participants aged 20-60 years were enrolled into the study after informed consent was obtained. Ultra Nattokinase (200 mg) and maltodextrin (200 mg) were used as the investigation product and placebo, respectively, and were orally administered at a dose of one tablet 3 times a day, after meals for 9 weeks. The following parameters were evaluated: fibrinogen, activated partial thromboplastin time (aPTT), fibrin degradation product (FDP), prothrombin time (PT), plasminogen activator inhibitor-1 (PAT-1), and bleeding time (BT). The direct and residual effects at different time points were measured to evaluate the efficacy, and the side effects including its occurrence and severity were evaluated to determine the safety of Ultra Nattokinase. For statistical analysis, the intent-to-treat (ITT) group was selected and unpaired t-test was used for one-tailed test at a 5% significance level.
Results: In the ITT group, the direct effect of nattokinase on FDP was statistically significant (P=0.0292). Nattokinase was not associated with any serious side effect.
Conclusion: Ultra Nattokinase can be safely used to Korean people according to our study. Further, it can be used as an adjuvant therapy or a health food for those at risk of vascular disease.
Keywords: Ultra Nattokinase; Fibrin Degradation Product; Fibrinolysis; Safety
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