Safety Evaluation of Long-Term Ingestion of Cladosiphon okamuranus Fucoidan in Healthy Subjects. A Randomized, Double-blind, Placebo-controlled, Parallel Study.
- Conditions
- ot applicable
- Registration Number
- JPRN-UMIN000028363
- Lead Sponsor
- SOUTH PRODUCT Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
People who meet any of the following conditions will be excluded. 1.Who regularly use intestinal drugs and laxative (including strong laxatives and enema) 2.Who can not stop intake the health food to relive constipation (including Food for Specified Health Uses (FOSHU)) during the screening period. 3.Who use medicine such as antibiotics that affect digestion and absorption. 4.Who can not stop intake food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or enhanced with oligosaccharide, dietary fiber and/or the health food to relive constipation (including Food for Specified Health Uses (FOSHU)) and/or containing a large amount of sugar alcohol during the screening period. 5.Who have allergic to food. 6.Who have serious diseases requiring an urgent treatment, or who accept severe complication. 7.Who has a medical history of diseases or surgery affecting digestion, absorption and bowel movement (except for appendicectomy). 8.Who are judged unsuitable for this study based on subject questionnaire. 9.Who is pregnant or willing to be pregnant or brest-feeding during this study. 10.Who has a current or history of drug dependence and/or alcoholism. 11.Who are participated in another clinical trial that intake/apply any of food, drug, and cosmetics, or willing to be that. 12.Who are judged unsuitable for this study by test responsibility doctor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety evaluation items: Examination by a physician in charge, physical examination findings, clinical laboratory findings(Hematological test, Biochemical test, Urine test), subject symptoms at 4 weeks, 8 weeks and 12 weeks ingestion.
- Secondary Outcome Measures
Name Time Method