NCT00749801

Efficacy and Safety of Geneferm Nattokinase

A Randomized, Double-Blind, Placebo-Controlled, Parallel Comparison Study to Evaluate the Efficacy and Safety of Oral Administration of Nattokinase (From GeneFerm Biotechnology Co., Ltd.) Taken by Dyslipidemia Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Chi Mei Medical Hospital · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Nattokinase, first found by Dr. Hiroyuki Sumi in 1980, is a potent fibrinolytic enzyme extracted from Natto, a popular soybean fermented food in Japan. It was confirmed that oral administration of nattokinase (or natto) produced a mild and frequent enhancement of the fibrinolytic activity in the plasma as indicated by the fibrinolytic parameters and the production of tissue plasminogen activator. Other studies also showed a reduction in lipid peroxidation and improvement of lipid metabolism. Short-term effect (less then 10 days) of oral administration of nattokinase on both animal and human subjects has been studied and reported. However, whether nattokinase possesses a beneficial effect to dyslipidemic patients remains unclear. The aim of this study is to investigate the long-term effect (six month) of the mono and multiple formulae of nattokinase, change of BP, lipid and fibrinolytic factors from baseline and 6 months on dyslipidemic patients.

Detailed description

This study will employ a randomized, double-blind, placebo-controlled, parallel-group design. Adult men and women who met the inclusion/exclusion criteria and gave consent to participate were randomly assigned to one of the three groups: Group A: nattokinase-mono formula (18 subjects); Group B: nattokinase compound (multiple formulae) (18 subjects); Group C: placebo (10 subjects). Laboratory tests, including TG, total cholesterol, LDL-C, HDL-C, fibrinogen, D-Dimer, uric acid, vital signs and body weight will be evaluated at screening visit, 1 month, 3 months, 6 months visits after the initiation of treatment. Vital signs and body weight will be measured at every visits. Patient self-evaluation of tolerance and physical improvement will be assessed by a Patient Questionnaire at each visit. Each patient will be carefully monitored for the development of any adverse events (AE). The change of all lab tests and vital signs will be plotted and compared against time. Wilcoxon Signed-Rank test will be performed to compare the baseline and 6 months after the initiation of administration. Change from baseline for all lab and vital evaluations will be compared among three groups by Analysis of Variance (ANOVA) followed by LSD multiple comparison.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Nattokinase	2 capsules in the morning and before bed-time daily

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-03-01
• Completion: 2008-04-01
• First posted: 2008-09-09
• Last updated: 2008-09-09

Locations

1 site across 1 country: Taiwan