Status:
COMPLETED
Efficacy and Safety of Natto Extract
Lead Sponsor:
Changhua Christian Hospital
Conditions:
Thrombosis
Cardiovascular Diseases
Eligibility:
All Genders
20-70 years
Phase:
PHASE4
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 patie...
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 ...
Eligibility Criteria
Inclusion
- In order to be enrolled in the study, potential study subjects must meet the following inclusion criteria:
- Men and non-pregnant women who are at least 20 and younger than 70 years of age.
- Subjects who are, in the opinion of the Investigator, able to comply with the requirements of the study.
- 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:
- Subjects have no risk factors of cardiovascular diseases (see Group C) or chronic renal diseases in the history.
- 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:
- Patients have coronary artery disease (CAD); OR
- Patients have peripheral arterial occlusive disease (PAOD); OR
- Patients have history of stroke; OR
- Patients have history of transient ischemic attack (TIA); OR
- Patients have history of pulmonary embolism (PE); OR
- Patients have history of deep vein thrombosis (DVP); OR
- 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
- In order to be enrolled in the study, potential study patients must not have any of the following exclusion criteria:
- Known allergies to the component of study product.
- Current use of warfarin.
- Patients have active disease status.
- Patients have acute disease, and in the opinion of investigators, are not suitable to participate in this study.
- Group-specific exclusion criteria:
- Group A:
- Patients have coronary artery disease (CAD).
- Patients have peripheral arterial occlusive disease (PAOD).
- Patients have history of stroke.
- Patients have history of transient ischemic attack (TIA).
- Patients have history of pulmonary embolism (PE).
- Patients have history of deep vein thrombosis (DVP).
- 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.
- Patients have history of chronic renal diseases.
- Male subjects have Creatinine\>1.4 mg/dl; Female\>1.3 mg/dl.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00447434
Start Date
June 1 2005
End Date
October 1 2005
Last Update
March 14 2007
Active Locations (1)
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1
Changhua Christian Hospital
Changhua, Taiwan, 500