A 8 weeks, randomized, double-blind human trial to evaluate the efficacy and safety of Fermented soybean(Doenjang powder)on intestinal microflora and menopausal women's health

Wonkwang University Hospital0 个研究点目标入组 60 人开始时间: 待定最近更新: 2023年12月19日

试验速览

暂无简介。

•1) Women aged 45-70 years at the screening test
•2) Postmenopausal women(amenorrhea for more than 12 months)
•3) BMI = 23 kg/m^2 at the screening test
•4) Subjects who agree to participated in the study and sign the informed consent form at the screening test

•1) Women who is taking hormone therapy within 3 months prior to the trial
•2) History of endometrial proliferation, uterine carcinoma, endometrial cancer, breast cancer, or sex hormone-related cancer
•3) A person who has received or has received chemotherapy or radiation therapy that may affect ovarian function
•4) Those with a history of significant hypersensitivity reactions to soybean and Doenjang ingredients
•5) Patients who have received antipsychotic medication within three months before screening test
•6) Patients who have or are suspected of alcoholism or substance abuse
•7) Patients who have participated in other human trials within three months before screening test
•8) Laboratory test by show the following results
•? ALT, AST > 3-fold of normal range
•? Serum creatinine > 2.0 mg/dl
•9)Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes

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