Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00447434
Status:
COMPLETED
Last Update Posted:
2007-03-14
First Post:
2007-03-13
Brief Title:
Efficacy and Safety of Natto Extract
Sponsor:
Changhua Christian Hospital
Organization:
Changhua Christian Hospital
Study Overview
Official Title:
An Open-Label Parallel Comparison Study to Evaluate the Effect of Oral Administration of Nattokinase Taken by Normal Subjects Patients Under Dialysis and Patients of Cardiovascular High Risk Groups
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 inclusionexclusion 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None