KCT0001458
Completed
未知
Clinical study for effects on menopasual symtom and blood vessel using combination of Kudzu and foxglove roots extract plus exercise
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Endocrine, nutritional and metabolic disease
- Sponsor
- Ewha Womans University
- Enrollment
- 150
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) The particioants who give informed consent before the start
- •2\) 45\~60 years old
- •3\) Postmenopause (defined as at least 12 months amenorrhoea) or Perimenopause (defined as having no more than one menstrual period during the 3 months before recruitment and having follicle stimulating hormone\>40 IU/L) women
- •4\) Women with moderate to severe menopausal symptoms (Kupperman index total score \= 20\)
- •5\) Fasting LDL\-cholesterol level \= 130mg/dL
- •6\) Women with low quality of the meal (recommended food score \= 36\)
- •7\) Fasting blood glucose \= 100 mg/dl
- •8\) glycated hemoglobin (HbA1c) \= 5\.7% and \= 6\.4%
- •9\) BMI: \= 23kg/m2
Exclusion Criteria
- •1\) Subjects who performed constant exercises at least 3 months prior to the first visit
- •2\) Subjects who cannot participate in an exercise program
- •3\) Subjects with surgical or chemotherapy induced menopause 4\) Subjects who have a history of breast cancer orabnormality depicted on a mammogram5\) Subjects who received hormone therapy within 6 months before the first visit
- •6\) Subjects who take excessive amount of isoflavones (\=56 mg/day)
- •7\) Subjects who consumed the functional food within 4 weeks prior to the first visit
- •8\) Subjects who took medical supplies within 4 weeks prior to the first visit : Sleep iaid drug, antidepressant,selective estrogen receptor modulator, hypocholesterolemic drug, antihypertensive drugs, antidiabetes drugs, bisphosphonate, calcitonin
- •9\) Subjects who have been vaginal bleeding without diagnosis
- •10\) Subjects who have a history of endometrial hyperplasia, endometrial cancer, sex steroid dependant organ tumors
- •11\) Subjects who have a history of severe migraine, thromboembolism, cerebrovascular disease, cardiovascular disease within 1 year prior to the first visit
- •12\) Subjects with hepatic or renal dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level \> 2 times the upper limit of normal, Creatinine \> 2\.0 mg/dL)
Outcomes
Primary Outcomes
Not specified
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