A human study to evaluate safety and effectiveness of Tetragonia tetragonoides extract on menopausal symptoms in postmenopausal wome

Not Applicable

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0002616
• Lead Sponsor: Ewha Womans University Medical Center

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: ot yet recruiting
• Sex: Female
• Target Recruitment: 80

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)

Exclusion Criteria

1) Subjects with surgical or chemotherapy induced menopause, a history of breast cancer or abnormal vaginalbleeding without diagnosis
2) Subjects who received hormone therapy within 6 months before the first visit
3) Subjects who consistently consumed the functional food related to postmenopause, bone health, blood glucose, blood lipid(cholesterol, triglyceride), blood pressure or blood flow within 1 month prior to the first visit
4) Subjects who took medical supplies within 4 weeks prior to the first visit : Sleep iaid drug, antidepressant,selective estrogen receptor modulator, antihyperlipidemic agent, antihypertensive agent, antidiabetic agent, bisphosphonate or calcitonin
5) Subjects who have a history of endometrial hyperplasia, endometrial cancer, sex steroid dependant organ tumors
6) Subjects who have a history of severe migraine, thromboembolic disorders, cerebrovascular disorders, cardiovascular disease within 1 year prior to the first visit
7) Subjects with hepatic or renal dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 3 times the upper limit of normal, Creatinine > 2.0 mg/dL), uncontrolled hypertension (systolic blood pressure/diastolic blood pressure > 140/90 mmHg), thyroid disease, diabetes or hyperlipidemia
8) drug addicts or alcoholics
9) Subjects who performed constant severe exercises at least 3 months prior to the first visit
10) Sensitive to test materials
11) Subjects who has participated in another clinical trial within 1 month prior to the first visit
12) Any condition that the principal investigator believes may put the subjects at undue risk

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Climacteric symptoms questionnaire

Secondary Outcome Measures

Name	Time	Method
Markers of lipid metabolism ;Markers of bone metabolism ;Markers of safety, etc.