Clinical study for effects on menopasual symtom and blood vessel using combination of Kudzu and foxglove roots extract plus exercise

Not Applicable

Completed

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0001458
• Lead Sponsor: Ewha Womans University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 150

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)
13) Hypertensive subjects Systolic blood pressure(SBP)/Diastolic blood pressure(DBP) = 140/90 mmHg), subjects with thyroid disease (thyroid stimulating hormone(TSH)<0.55 uIU/mL or >4.78uIU/mL), diabetes, subjects with hyperlipidemia
14) drug addicts or alcoholics
15) Subjects sensitive to test materials
16) Subjects who has participated in another investigational study within 4 weeks prior to the first visit

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Climacteric symptoms questionnaire ; vascular biomarkers

Secondary Outcome Measures

Name	Time	Method
ipid metabolism profiles;inflammation biomarkers