Efficacy and safety of HPC-03 for menopausal symptom
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0002254
- Lead Sponsor
- Hanpoong Pharm & Foods
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 150
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Modified Kupperman Index
- Secondary Outcome Measures
Name Time Method endometrial thickness;Alkaline phosphatase;Osteocalcin;Urine N-terminal cross-linker telopeptidase;estradiol;Follicle-stimulating hormone (FSH)