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
Data Collection
Cardiovascular Diseases+1
+ Thrombosis
+ Vascular Diseases
Prevention Study
Summary
Study start date: June 1, 2005
Actual date on which the first participant was enrolled.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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.45 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 20 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * In order to be enrolled in the study, potential study subjects must meet the following inclusion criteria: 1. Men and non-pregnant women who are at least 20 and younger than 70 years of age. 2. Subjects who are, in the opinion of the Investigator, able to comply with the requirements of the study. 3. Subjects who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving investigational product. Group-specific inclusions criteria: Group A: 1. Subjects have no risk factors of cardiovascular diseases (see Group C) or chronic renal diseases in the history. 2. Male subjects have Creatinine≦1.4 mg/dl; Female≦1.3 mg/dl. Group B: 1\. Patients have been receiving dialysis at the same institute for at least 3 months. Group C: 1. Patients have coronary artery disease (CAD); OR 2. Patients have peripheral arterial occlusive disease (PAOD); OR 3. Patients have history of stroke; OR 4. Patients have history of transient ischemic attack (TIA); OR 5. Patients have history of pulmonary embolism (PE); OR 6. Patients have history of deep vein thrombosis (DVP); OR 7. Patients have more than 2 major risk factors of cardiovascular disease (CVD) listed by National Health Insurance guidelines such as hypertension, smoking, diabetes mellitus (DM), atrial fibrillation (AF), lipid disorder, overweight, physical inactivity, etc. Exclusion Criteria: * In order to be enrolled in the study, potential study patients must not have any of the following exclusion criteria: 1. Known allergies to the component of study product. 2. Current use of warfarin. 3. Patients have active disease status. 4. Patients have acute disease, and in the opinion of investigators, are not suitable to participate in this study. Group-specific exclusion criteria: Group A: 1. Patients have coronary artery disease (CAD). 2. Patients have peripheral arterial occlusive disease (PAOD). 3. Patients have history of stroke. 4. Patients have history of transient ischemic attack (TIA). 5. Patients have history of pulmonary embolism (PE). 6. Patients have history of deep vein thrombosis (DVP). 7. Patients have more than 2 major risk factors of cardiovascular disease (CVD) listed by National Health Insurance guidelines such as hypertension, smoking, diabetes mellitus (DM), atrial fibrillation (AF), lipid disorder, overweight, physical inactivity, etc. 8. Patients have history of chronic renal diseases. 9. Male subjects have Creatinine\>1.4 mg/dl; Female\>1.3 mg/dl.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location