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Efficacy and Safety of Natto Extract

NCT00447434 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2007-03-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Natto extract (Nattokinase)

Sponsors & Collaborators

  • Changhua Christian Hospital

    lead OTHER

Principal Investigators

  • Chien-Hsun Hsia, MD · Changhua Christian Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-06-30
Completion
2005-10-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00447434 on ClinicalTrials.gov