Natural or surgical menopause for 36 months - Menopause - Genitourinary Symptoms of Menopause (GSM) - Quality of life - Probiotics
Conditions
Interventions
Probiotics (Thai Strains, Lactobacillus Paracasei, and Bifidobacterium Animalis, each at least 10 9 CFU/g) in a soft gel capsule
Plant extracts containing Soy germ 100 mg, Dong Quai 80 mg, Chameleon p
Experimental Dietary Supplement,Placebo Comparator Dietary Supplement
Probiotics plus Plant Extracts,Placebo
Sponsors
Srinakharinwirot University
Eligibility
Sex/Gender
Female
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 40 - 60 who have been in menopause (either naturally or following surgery to remove the uterus and ovaries) for at least 36 months (3 years) since their last menstruation. 2. Meet at least one of the following criteria: have symptoms related to the genital system, urinary tract system, or sexual activity that occur after menopause, as assessed by the Menopause Rating Scale (MRS). They should not have received hormone replacement therapy before or have discontinued it for at least 6 months. 3. Breast examination shows no lumps and initial internal examination finds no lumps in the cervix, uterus, or ovaries. 4. No chronic diseases, including diabetes requiring medication, hypertension requiring medication, endocrine diseases like thyroid disorders, heart disease, liver disease, kidney disease, breast cancer, ovarian cancer, uterine cancer, or depression. 5. No history of allergy to soy or soy derivatives. 6. Willing to participate in the research project, including undergoing internal examinations, blood tests, laboratory tests, and ultrasound examinations, and able to attend follow-up appointments as scheduled.
Exclusion criteria
Exclusion criteria: 1. Volunteers who are treating a vaginal infection or urinary tract infection by taking antibiotics or who have recently stopped taking antibiotics for treating bacterial infections from other causes within the last 2 weeks. 2. Have a history of severe adverse effects from using hormone replacement therapy, any soy-based products, and extracts from Dong Quai, Chameleon plant, or rosehip. 3. Have a history of lumping the breast or an abnormal breast cancer screening result that has not been conclusively resolved. 4. Have a history of abnormal bleeding or irregular menstruation within the past 36 months. 5. Have a history of gastrointestinal symptoms, including gastritis, diarrhea, chronic constipation, or irritable bowel syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vaginal microbiome Day 0 and Day 84 Metagenomic 16S RNA sequencing to determine taxon diversity and abundance,Vaginal maturation index Day 0 and Day 84 Grades determined microscopically ,Fasting glucose level Day 0 and Day 84 Blood chemistry (g/dl) ,Lipid profile (LDL, HDL, TG, total cholesterol) Day 0 and Day 84 Blood chemistry ,Adverse effects Day 42 and Day 84 clinical review, history taking | — |
Secondary
| Measure | Time frame |
|---|---|
| Menopause rating scale Day 0, Day 42, Day 84 Standardized questionnaire,Menopause Specific Quality of Life (MEN-QOL) Day 0, Day 42, Day 84 Standardized questionnaire | — |
Countries
Thailand
Contacts
Public ContactAmarin Narkwichean
Department of Obstetrics and Gynecology, Faculty of Medicine, Srinakharinwirot University
Outcome results
None listed