The verification study for safety evaluation of bamboo cellulose nanofiber long-term administration in human: an open-label trial
Not Applicable
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000024030
- Lead Sponsor
- ORTHOMEDICO, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Currently taking medicines and/or herbal medicines 4. Allergic to medicines or foods related to the test food of this trial 5. Pregnant, lactating, or planning to get pregnant during the trial period 6. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial 7. Judged unsuitable for participating in this trial by physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Body measuring 2. Physical examination 3. Urinalysis 4. Blood test 5. Subjective symptom *1 Perform examinations and tests at 0 weeks, at 4, 8 and 12 weeks after ingestion and at 4 weeks for follow-up period
- Secondary Outcome Measures
Name Time Method