Efficacy and Safety of Geneferm Nattokinase
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ClinicalTrials.gov Identifier: NCT00749801 |
Recruitment Status :
Completed
First Posted : September 9, 2008
Last Update Posted : September 9, 2008
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Condition or disease | Intervention/treatment | Phase |
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Hyperlipidemia | Drug: Nattokinase | Not Applicable |
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 assigned to one of the three groups: Group A: nattokinase-mono formula (18 subjects); Group B: nattokinase compound (multiple formulae) (18 subjects); Group C: placebo (10 subjects).
Laboratory tests, including TG, total cholesterol, LDL-C, HDL-C, fibrinogen, D-Dimer, uric acid, vital signs and body weight will be evaluated at screening visit, 1 month, 3 months, 6 months visits after the initiation of treatment. Vital signs and body weight will be measured at every visits.
Patient self-evaluation of tolerance and physical improvement will be assessed by a Patient Questionnaire at each visit. Each patient will be carefully monitored for the development of any adverse events (AE).
The change of all lab tests and vital signs will be plotted and compared against time. Wilcoxon Signed-Rank test will be performed to compare the baseline and 6 months after the initiation of administration. Change from baseline for all lab and vital evaluations will be compared among three groups by Analysis of Variance (ANOVA) followed by LSD multiple comparison.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 47 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel Comparison Study to Evaluate the Efficacy and Safety of Oral Administration of Nattokinase (From GeneFerm Biotechnology Co., Ltd.) Taken by Dyslipidemia Patients |
Study Start Date : | May 2007 |
Actual Primary Completion Date : | March 2008 |
Actual Study Completion Date : | April 2008 |
Arm | Intervention/treatment |
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Active Comparator: A
nattokinase-mono formula (3500FU)
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Drug: Nattokinase
2 capsules in the morning and before bed-time daily
Other Names:
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Experimental: B
Nattokinase compound-multiple formulae
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Drug: Nattokinase
2 capsules in the morning and before bed-time daily
Other Names:
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Placebo Comparator: C
Placebo
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Drug: Nattokinase
2 capsules in the morning and before bed-time daily
Other Names:
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- Fibrinogen, FDP (fibrin degradation product), D-dimer, Total cholesterol, LDL-C (Low-density lipoprotein cholesterol), HDL-C (High-density lipoprotein cholesterol), Triglyceride (TG), and Uric acid [ Time Frame: screening, day 0, weeks 4, 13, 26 ]
- Vital signs and self-evaluated questionnaire [ Time Frame: screening, day 0, weeks 4, 13, 26 ]

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749801
Taiwan | |
Chi Mei Medical Hospital | |
Tainan, Taiwan, 710 |
Study Chair: | Nae-Cherng Yang, PhD | Chung Chou Institute of Technology |
Responsible Party: | Nae-Cherng Yang, Chungchou Institute of Technology, Changhua, Taiwan |
ClinicalTrials.gov Identifier: | NCT00749801 |
Other Study ID Numbers: |
Geneferm-N01 |
First Posted: | September 9, 2008 Key Record Dates |
Last Update Posted: | September 9, 2008 |
Last Verified: | September 2008 |
drug naive Dyslipidemic nattokinase fibrinolytic |
Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |