None listed
Conditions
Interventions
Dietary Supplement : DW2013 Group : Take 2 capsules once daily for 12 weeks.
Placebo Group : Take 2 capsules once daily for 12 weeks.
Sponsors
Dongwha Pharmaceutical
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women aged 45 to 60 years 2) Women meeting at least one of the following criteria: ? Postmenopausal (at least 1 year since the last menstrual period) ? In menopausal transition (no menstruation for more than 3 months and FSH level exceeding 30 mIU/mL) 3) Women with a Kupperman Index (KI) score of 25 or higher at Visit 1 4) Women experiencing an average of 5 or more hot flashes per day between Visit 1 and Visit 2 5) Those who have agreed to participate in the clinical trial and signed the informed consent form (ICF) prior to the start of the study
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(However, women who have been cured of cancer, excluding endometrial cancer, breast cancer, or hormone-related cancers, may participate if at least 5 years have passed since their cure) 2) Women with a body mass index (BMI) of less than 18 kg/m² or greater than 30 kg/m² 3) Women with a history of endometrial hyperplasia, endometrial cancer, cervical cancer, breast cancer, or hormone-related cancers 4) Women who have undergone a hysterectomy or uterine resection. 5) Women with undiagnosed abnormal uterine bleeding occurring more than 1 year post-menopause. 6) Women with a history of severe migraines, thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or a past history of coronary angioplasty within the last year prior to Visit 1. 7) Individuals with severe mental illnesses such as depression or anxiety disorders, or currently taking psychiatric medications, including antidepressants and sedatives (e.g., SSRIs, Gabapentin, Benzodiazepines). 8) Women who have used thyroid hormone preparations, clonidine, anticoagulants, antiplatelet agents (e.g., warfarin, clopidogrel), or osteoporosis treatments (e.g., selective estrogen receptor modulators, bisphosphonates) within 3 months prior to Visit 1. 9) Women who have used hormone preparations or similar hormonal agents (e.g., black cohosh, St. John's Wort, red clover, agnus castus) within 3 months prior to Visit 1. 10) Women who have taken menopausal-related medications or dietary supplements, or prescribed herbal medicine for menopausal symptom relief within 30 days prior to Visit 1. 11) Individuals who have received systemic antibiotics, systemic antimicrobial agents, or intestinal regulators within 2 weeks prior to Visit 1. 12) Women who have taken probiotics, prebiotics, or consumed fermented dairy products or probiotic food products at least 4 times a week continuously within 2 weeks prior to Visit 1. 13) Women with clinically significant abnormalities on mammography or PAP smear (e.g., BI-RADS Category 0 or 3 or higher; no abnormalities up to ASCUS on PAP smear). 14) Women with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m². 15) Women with AST (GOT) or ALT (GPT) levels more than three times the upper limit of normal for the conducting institution. 16) Women with uncontrolled hypertension (systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg, measured after 10 minutes of rest). 17) Women with uncontrolled diabetes (HbA1c greater than 7.0% or those who have initiated diabetes medication within 3 months prior to Visit 1). 18) Women who have initiated new antihyperlipidemic medications within 30 days prior to Visit 1 (however, participation is allowed if they maintain the same type and dosage of previously prescribed medications during the study). 19) Women with TSH levels less than 0.1 µIU/mL or greater than 10 µIU/mL. 20) Women consuming an average of 20 g or more (140 g/week) of alcohol per day within 4 weeks prior to Visit 1. 21) Women who are heavy smokers (more than 20 cigarettes per day). 22) Women who have participated in other interventional clinical trials within the last 3 months prior to Visit 1, or plan to participate in other interventional c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Kupperman Index Total score | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual item scores of the Modified KI ;Total score and individual item scores of the MRS;Total score and domain-specific scores of the MENQOL-K;Hot flash score (frequency and severity of symptoms);Blood lipids (Total Cholesterol, Triglyceride, HDL-Cholesterol, LDL-Cholesterol);Blood markers (TNF-a, IL-6, IL-10, RANK, RANKL, Osteocalcin, ALP);Fecal microbiota | — |
Countries
Korea, Republic of
Contacts
Public ContactJiyoung Lee
Konkuk University Medical Center
Outcome results
None listed