A human study to evaluate the efficacy and safety of rice bran extract on climacteric symptoms in perimenopausal and postmenopausal wome
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Registration Number
- KCT0003282
- Lead Sponsor
- S&D
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 60
1) Subject who agrees to participate in the study and signs the informed consent form
2) Women aged 45–65 years
3) Post-menopausal (amenorrhea = 12 months) or peri-menopausal (amenorrhea = 3 month & follicle stimulating hormone (FSH) > 30 IU/L)
4) Moderate or severe menopausal symptoms (score = 15), identified by the Kupperman index
1) Subjects with surgical or chemotherapy induced menopause, Subjects who have been vaginal bleeding without diagnosis
2) Hormone therapy within the past 6 months prior to the first visit
3) Subjects who consumed the functional food or oriental medicine that can affect menopausal health, blood glucose, blood lipids (triglycerides, cholesterol, etc.), blood pressure, blood circulation within 4 weeks prior to the first visit
4) Use of medication within the past 4 weeks: sleep-inducing agents, antidepressants, selective estrogen receptor modulators, antihyperlipidemic drugs, antihypertensive drugs, beta-blockers, antidiabetic drugs. However, in the case of beta-blockers, they may be included in the subject if they are expected to have no change of taking dose for one year or have no change of taking dose during the study.
5) History of breast cancer, endometrial hyperplasia, uterine endometrial cancer, and sex steroid dependent organ tumors or subjects with clinically significant abnormality in thyroid function test, mammography, or pelvic ultrasound
6) Abnormality in renal and liver function (eGFR < 60; ALT or AST > the upper limit of normal levels x 2.5), uncontrolled hypertension (systolic blood pressure (SBP)/diastolic blood pressure (DBP) >160/100 mmHg), thyroid disease, diabetes mellitus, hyperlipidemia
7) History of severe migraine headache, thromboembolic disorders, cerebrovascular disorders, serious cardiovascular conditions within 1 year
8) Beck Depression Inventory score =13, = 29
9) History of drug abuse, or alcoholism
10) Subjects who performed continuous high-intensity exercises at least 3 months prior to the first visit (=10 hours/week)
11) Allergy (hypersensitivity) to any of the materials used in the study
12) Subject who participated in other clinical trial within 1 month
13) Other cases considered inappropriate for the clinical trial by the investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Kupperman index
- Secondary Outcome Measures
Name Time Method Climacteric symptoms questionnaire;Markers of lipid metabolism;Anthropometric markers;Safety markers