None listed
Conditions
Interventions
Dietary Supplement : 1. Daily intake and ingestion method
• Test foods (HPC-03): Take 2 tablets twice a day with water in the meals (2g / day as HPC-03)
• Placebo: In the same way as the test food.
2
Sponsors
Hanpoong Pharm & Foods
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women 40 to 60 years old who have passed one year or more since the last menstrual period 2) Women with a kupperman index score of 20 or higher 3) Women who have agreed to participate in this trial before the start of the clinical trial and who have written an informed consent
Exclusion criteria
Exclusion criteria: 1) Women with a body mass index (BMI) greater than 30 kg / m2 2) Women using hormone preparations such as female hormones or similar hormone preparations (plant extracts, etc.) within 3 months 3) Women with a history of endometrial hyperplasia, uterine cancer, endometrial cancer, breast or breast disease, sex hormone related cancer 4) A woman with a history of severe migraine within the past 1 year, diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or coronary angioplasty 5) Women with severe mental illnesses such as depression and anxiety disorder, or those currently taking psychotropic drugs such as antidepressants 6) Women with irregular uterine bleeding after 1 year of menopause 7) Patients with uncontrolled hypertension (160 / 100mmHg or higher, after 10 minutes of clinical test subjects) 8) Patients with diabetes whose blood sugar is not controlled (fasting glucose 180 mg / dL or diabetes mellitus within 3 months) 9) Those with uncontrolled thyroid disease (those who are considered to be able to participate in this trial by the tester can participate) 10) drug or alcohol abuser 11) If ALT(Alanine transaminase ) or AST(Aspartate transaminase ) exceeds 3 times the normal upper limit of the research institute 12) If creatinine exceeds twice the upper limit of the normal level of research institute 13) Mammography / PAP(Papanicolaou) smear If a clinically significant abnormality [ Breast imaging-reporting and data system (BIRADS) Category 0 or 3 or more, PAP smear is not abnormal up to ASCUS(Atypical Cells of Undetermined Significance)] is confirmed (BI-RADS Category 0, ) 14) If you have participated in another clinical trial within one month of the start of this trial or plan to participate in another clinical trial during the trial period 15) If the tester judges that the test is inappropriate for this clinical trial 16) Women using thyroid hormone preparations, clonidine, anticoagulants or antithrombotic agents (Warfarin, Clopidogrel, etc.) within 3 months 17) Women who took medicines or health functional foods related to women's menopause within a month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Kupperman Index | — |
Secondary
| Measure | Time frame |
|---|---|
| endometrial thickness;Alkaline phosphatase;Osteocalcin;Urine N-terminal cross-linker telopeptidase;estradiol;Follicle-stimulating hormone (FSH) | — |
Countries
Korea, Republic of
Contacts
Public ContactJae Hoon LEE
Yonsei University Health System, Severance Hospital
Outcome results
None listed