None listed
Conditions
Interventions
Dietary Supplement : Experimental(low-dose): KGC02HC (400 mg/tablet (total 55 mg)), once a day, 1 tablet at a time
Experimental(high-dose): KGC02HC (400 mg/tablet (total 110 mg)), once a day, 1 tablet
Sponsors
Korea Ginseng Corporation
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Adult women aged 45 years to 65 years with a Kupperman Index score of 25 or higher 2) Those who meet one of the following menopause criteria Women with spontaneous amenorrhoea for 12 months after the last menstrual period Women with spontaneous amenorrhoea for 6 months with a blood FSH concentration > 40 mlU/mL 3) Those whose average number of hot flashes is 7 or more per week 4) Voluntarily decided to participate in this human clinical trial and agreed in writing to comply with the precautions during the human clinical trial.
Exclusion criteria
Exclusion criteria: 1) Participation in other human clinical trials within the last 3 months prior to screening 2) Patients who have undergone bilateral oophorectomy, endometriosis, endometrial hyperplasia, endometrial cancer, breast cancer, and other sex hormone-related diseases. 3) It has not been 6 weeks since hysterectomy or hysterectomy. 4) Clinically significant abnormalities confirmed by mammography (Criteria for significant abnormalities: BI-RADS category 0 or 3 or higher. However, if BI-RADS category 0, patients may be enrolled after additional imaging studies or comparative evaluation with previous studies) 5) Blood FSH concentration of 30 mlU/mL or less. 6) Endometrial thickness > 6 mm on transvaginal ultrasound examination 7) Clinically significant abnormalities in thyroid hormone levels (however, temporary abnormalities can be included at the discretion of the principal investigator) 8) History of use of any of the following agents within 3 months prior to screening : Hormonal or analogue preparations (estrogen, estradiol, estrophate, ethinylestradiol-containing oral preparations or vaginal tablets, progestin preparations, corticosteroid preparations, thyroid hormone preparations, Tibolone, etc,) Osteoporosis medications [Selective Estrogen Receptor Modulators (SERMs), Bisphosphonates, Calcitonin, Parathyroid hormone preparations, etc. 9) Consumption of herbal medicines or dietary supplements for the relief of menopausal symptoms within one month prior to screening (medicines and dietary supplements containing equine extracts, liquorice, dang quai, sarsaparilla, red clover, isoflavones, St John's wort, soybean extracts, sprouted fermented soybean extracts, red ginseng extracts, Panax ginseng extract, rhubarb extract, thistle complex extract, white thistle complex, pomegranate extract, schisandra extract, pycnogenol extract, evening primrose seed oil (gamma-linolenic acid), menopausal lactobacillus YT1, products containing functional probiotics and lactic acid bacteria, jadeite, calcium preparations, vitamin D preparations, etc.) 10) Other serious cardiovascular, neurological (dysautonomia), respiratory, renal and urinary, musculoskeletal, gastrointestinal/liver and biliary disorders, hyperthyroidism, parathyroid-related disorders (hypo- and hyperparathyroidism. Parathyroid cancer), malignancies, pernicious anaemia, rheumatic diseases, infectious diseases, severe migraine, etc. 11) BMI exceeding 30.0kg/m2 12) Subjects with abnormal eating habits (vegetarians, bulimia nervosa, use of appetite suppressants, etc.) 13) Allergic to any of the components of the investigational product or similar ingredients 14) Patients with uncontrolled hypertension despite taking antihypertensive medication (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg when measured after 10 minutes of rest) 15) Uncontrolled diabetes (fasting blood glucose greater than or equal to 180 mg/dL or new initiation of medication for diabetes within 3 months) 16) Psychiatric diagnosis such as depression, anxiety disorder, sleep disorder, etc. within 3 months prior to screening and treated with medication or currently taking neuropsychiatric medication 17) Suspected alcoholism and drug abuse (appetite suppressants, narcotic patches, etc.) 18) Those who show the following results in diagnostic medical tests - AST, ALT levels 3 times the upper limit of the institution's reference range - eGFR <60 mL/min/1.73m2 factor 19) Those who are deemed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kupperman Index | — |
Secondary
| Measure | Time frame |
|---|---|
| Hot flashes score;Menopause Rating Scale;Beck Depression Inventory-II;Osteocalcin, BSAP, urine NTx;TC, TG, HDL, LDL | — |
Countries
Korea, Republic of
Contacts
Public ContactLee Seong
Dankook Univeristy Hospital
Outcome results
None listed