Safety evaluation of excessive ingestion of Cladosiphon okamuranus Fucoidan in healthy subjects. A Randomized, Double-blind, Placebo-controlled, Parallel Study. - Safety evaluation of excessive ingestion of Cladosiphon okamuranus Fucoidan in healthy subjects.

SOUTH PRODUCT Co., Ltd0 个研究点目标入组 30 人开始时间: 2017年8月1日最近更新: 2023年10月17日

适应症

试验速览

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•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.

发起方

SOUTH PRODUCT Co., Ltd