None listed
Conditions
Interventions
Dietary Supplement : Consumption of placebo or herbal formula (Pueraria lobata and Rehmannia glutinosa) for 12 weeks
Sponsors
Bundang CHA General Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Subject who voluntarily agrees to participate and signs in informed consent form 2) Women aged 45–60 years 3) Post-menopausal (amenorrhea = 12 m) or peri-menopausal (amenorrhea = 3 m & follicle stimulating hormone (FSH) > 40 IU/L) 4) Moderate or severe menopausal symptoms (score = 20), identified by the Kupperman index
Exclusion criteria
Exclusion criteria: 1) Surgical menopause 2) History of breast cancer or abnormal mammograms (BIRAIDS class >2) 3) Hormone therapy within the past 6 months 4) High dietary intake of isoflavones 5) Use of dietary supplement within the past 4 weeks : soy isoflavone, flaxseed, pomegranate, black cohosh, Cynanchum wilfordii, red clover 6) Use of medication within the past 4 weeks : sleep-inducing agents, antidepressants, selective estrogen receptor modulators, antihyperlipidaemic drugs, bisphosphonate, calcitonin 7) Undiagnosed abnormal vaginal bleeding 8) History of endometrial hyperplasia, uterine endometrial cancer, sex steroid dependant organ tumors 9) History of severe migraine headache within a year, thromboembolic disorders, cerebrovascular disorders, serious cardiovascular conditions 10) Abnormality in renal and liver function (alanine transferase (ALT) or aspartate transaminase (AST) > the upper limit of normal levels x 2, creatinine >2.0 mg/dL) 11) Uncontrolled hypertension (systolic blood pressure (SBP) / diastolic blood pressure (DBP) >140/90 mmHg), thyroid disease (thyroid stimulating hormone (TSH) 5.5 uIU/mL), diabetes mellitus(Hemoglobin A1C (HbA1c) >7%) 12) History of drug abuse, or alcoholism 13) Allergy(hypersensitivity) to any of the materials used in the study 14) Participation in other clinical trial within the previous 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Climacteric symptoms questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Markers of lipid metabolism ;Markers of bone metabolism;Markers of blood glucose;Markers of safety, etc. | — |
Countries
Korea, Republic of
Contacts
Public ContactRyu
Ewha Womans University
Outcome results
None listed