None listed
Conditions
Interventions
Dietary Supplement : WMP-Pro group : Intake of WMP-Pro(Probiotics complex 500mg/day) 1 capsule/day after meal for 12 weeks,
Placebo : Intake of Placebo 1 capsule/day after meal for 12 weeks.
Sponsors
Cell Biotech
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Woman aged between 45 and 60 years. 2) Woman who has passed one year since the last menstrual period or more than FSH 40 mIU / ml 3) Kupperman index score of 25 or higher 4) Woman who has agreed to participate in this study and written an informed consent
Exclusion criteria
Exclusion criteria: 1) Woman who is being treated for severe cardiovascular, immune system, respiratory system, gastrointestinal/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, infectious disease, and malignant tumor 2) BMI (Body Mass Index)> 30 Kg/m2 3) Woman who has hasmedical history such as endometrial hyperplasia, cervical cancer, endometrial cancer, breast cancer, or estrogen dependent tumor 4) Woman who diagnosed with intestinal diseases (such as enterocolitis, inflammatory bowel disease, Crohn's disease, irritable bowel syndrome, etc.). 5) Woman with metrorrhagia after one year of menopause 6) Drug or alcohol abuser 7) Woman who was given a hysterectomy 8) Woman who has severe migraine within the last year, thromboembolism, cerebrovascular disease, or cardiovascular disease 9) Woman who has severe mental illness, such as depression and anxiety disorder, or are currently taking psychosomatic drugs such as antidepressants 10) Woman who is taking or administering a therapeutic agent for osteoporosis, such as a bisphosphonate preparation 11) Woman who used thyroid hormone, Clonidine, anticoagulant agent(Warfarin, Aspirin, Clipidogrel within 3 months 12) Woman who has used female hormones or similar hormone products (plant extracts, etc.) within 3 months 13) Woman who used complementary and alternative medicine within 1 month for menopause 14) Woman who has taken probiotics within 1 month 15) Woman who received systemic antibiotics within two weeks 16) Woman with uncontrolled hypertension(> 160/100mmHg) 17) Woman with uncontrolled hyperlipidemia (more than 300 mg / dL of triglycerides or more than 300 mg / dL of total cholesterol 18) Woman with uncontrolled DM (fasting glucose > 180mg/dL or started new DM drug within 3 months 19) Woman with thyroid disease whose TSH is less than or equal to 0.1 µU / ml or more than 10 µU / ml 20) Woman who has more than three times over the normal limit of ALT(GOT) or AST(GPT) 21) Woman who has two times over the normal limit of creatinine 22) Woman with abnormal mammography/PAP smear (BI-RADS Category > 3, PAP smear > ASCUS 23) Woman who has participated other clinical trial within 3 months or planned 24) Woman who is sensitive or allergic to test product ingredient 25) If investigator is deemed inappropriate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kupperman Index | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Modified KI 2) MRS(Menopause Rating Scale) 3) MENQoL 4) Hot flushes 5) Waist circumference 6) Equol 7) BSALP, OC, CTx 8) Urine NTx 9) HDL-C, LDL-C, Triglyceride 10) Endothelin-1, eNOS 11) Self-assessment for improvement | — |
Countries
Korea, Republic of
Contacts
Public ContactMinkyung Jeong
Cell Biotech
Outcome results
None listed