Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT00447434
Brief Summary:
Nattokinase is a potent fibrinolytic enzyme extracted from Natto. The objective of this study was to compare the efficacy of the natto extract taken by healthy volunteers, dialysis patients, and patients with cardiovascularrisk factors on the fibrinolytic factors and blood lipids. The study has two primary objectives: to evaluate the effect of oral intake of nattokinase in normal subjects, patients under dialysis, and patients of cardiovascular high risk group, and to compare the effect of oral intake of nattokinase among three groups.
Fifteen subjects, 20-70 years, for each group will be enrolled to take the capsules of natto extract orally for 2 months. Fibrinolytic factors, vital signs and blood lipids for efficacy, and body weight, renal function and self-administered questionnaire for safety will be assessed at screening, 3, 7, 28, and 56 days after the initiation of intake, and 2 weeks after the cease of intake.
Detailed Description:
This study will employ an open-label, parallel-group design. Adult men and women who meet the inclusion/exclusion criteria and give written consent to participate will be assigned to one of the three groups according to their condition: Group A- normal volunteers; Group B- patients under dialysis; Group C- patients of cardiovascular high risk group. Each group will enroll 15 subjects. After two to four weeks run-in period, subjects will be given nattokinase orally for 8 weeks, and will be asked to stop taking nattokinase for 2 weeks to evaluate the effect of long-term intake and cease of intake of nattokinase.
Laboratory tests, including fibrinogen, T-PA, PAI-1, D-dimer, total cholesterol, LDL-C, HDL-C, and TG, vital signs and body weight will be evaluated at screening visit, 3 days, 1 week, 4 weeks, 8 weeks, and 10 weeks (2 weeks after cease of intake) visits. Patient self-evaluation of tolerance and physical improvement will be assessed by a Patient Questionnaire at 3-day, and 1-, 4-, 8-, and 10-week visits. Each patient will be carefully monitored for the development of any adverse events (AE).
Study:
NCT00447434
Study Brief:
Protocol Section:
NCT00447434