Status:
COMPLETED
Efficacy and Safety of Geneferm Nattokinase
Lead Sponsor:
Chi Mei Medical Hospital
Collaborating Sponsors:
GeneFerm Biotechnology Co., Ltd.
Conditions:
Hyperlipidemia
Eligibility:
All Genders
40+ years
Phase:
NA
Brief 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 nat...
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...
Eligibility Criteria
Inclusion
- Men and non-pregnant women above 40 years of age.
- Dyslipidemic currently being untreated with lipid-lowering drugs. Dyslipidemia is defined as: Total cholesterol 200\~300 mg/dl; or Triglyceride 200\~500 mg/dl; or Low density lipoprotein-cholesterol 130\~200 mg/dl; or High density lipoprotein cholesterol \<40 mg/dl (male) and \<50 mg/dl (female).
- 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.
Exclusion
- Receipt of lipid-lowering drugs or device within 12 weeks.
- Myocardial infarction within the preceding 12 weeks.
- Recent major trauma (within 12 weeks).
- Recent surgery requiring anesthesia including coronary artery bypass graft (within 12 weeks).
- Recent hospitalization (within 12 weeks).
- Acute infection requiring current antibiotic therapy.
- Recent or abrupt change (within 1 month) in usual diet.
- Unstable medical condition or life expectancy less than 6 months.
- Known allergies to the component of study product.
- Patients have acute disease, and in the opinion of investigators, are not suitable to participate in this study.
- Total cholesterol \>300 mg/dl; or Triglyceride \>500 mg/dl; or Low density lipoprotein-cholesterol \>200 mg/dl.
- Current use of warfarin.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00749801
Start Date
May 1 2007
End Date
April 1 2008
Last Update
September 9 2008
Active Locations (1)
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1
Chi Mei Medical Hospital
Tainan, Taiwan, 710