Efficacy and Safety of HPC-03 for Postmenopausal Symptom

Study Overview
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Brief Summary
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In women, as the age increases, ovarian function is lost, resulting in the deficiency of female hormones, resulting in menopause, in which menstruation is permanently lost. The average age of menopause in Korean women is 49.7 years old, which is equivalent to 22.3% of the total female population. In addition, the increase in the number of women who experience early menopause due to environmental factors such as stress as a result of the increase in the number of women entering the society is also a major cause of the expansion of the market for menopausal women's health functional foods. Women's menopausal symptoms have been regarded as a natural process for everyone, but with the recent interest in health and the results of related studies, the perception that menopausal symptom management is necessary has spread. In traditional medicine of far east asia, danggui (Angelica gigas Nakai), taeunggung (Cnidium Rhizome), and broilers (Cinnamon bark) have been commonly used for postmenopausal symptoms improvement. However, scientific evidence for these foods are lacking. Therefore, in this study the investigators tried to examine the efficacy and safety of extracts of angelica gigas nakai, cnidium rhizome, and cinnamon bark in postmenopausal symptoms. This study is designed as double-blinded placebo control study.

Detailed Description
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The results of preclinical efficacy evaluation of HPC-03 (Angelica gigas Nakai complex extract) obtained by mixing materials mentioned above showed that increase of serum estrogen level and increase of bone mineral density (BMD) of femur due to ALP(Alkaline phosphatase ) inhibition, bone related index (BALP,bone-specific alkaline phosphatase ; CTX- 1,C-terminal telopeptide-1 ; Osteocalcin). Therefore, the investigators aimed to confirm the safety and efficacy of HPC-03 (a complex extract of Angelica gigas Nakai) which has been confirmed in preclinical studies, on the improvement of menopausal symptoms.

Official Title
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Efficacy and Safety of HPC-03(Extracts of Angelica Gigas Nakai, Cnidium Rhizome, and Cinnamon Bark) for Postmenopausal Symptom

Conditions
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Postmenopausal Period

Intervention / Treatment
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* Dietary Supplement: HPC-03
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 40 to 60 years old who have passed one year or more since the last menstrual period Women with a kupperman index score of 20 or higher 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: Women with a body mass index (BMI) greater than 30 kg / m2 Women using hormone preparations such as female hormones or similar hormone preparations (plant extracts, etc.) within 3 months Women with a history of endometrial hyperplasia, uterine cancer, endometrial cancer, breast or breast disease, sex hormone related cancer 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 Women with severe mental illnesses such as depression and anxiety disorder, or those currently taking psychotropic drugs such as antidepressants Women with irregular uterine bleeding after 1 year of menopause Patients with uncontrolled hypertension (160 / 100mmHg or higher, after 10 minutes of clinical test subjects) Patients with diabetes whose blood sugar is not controlled (fasting glucose 180 mg / dL or diabetes mellitus within 3 months) Those with uncontrolled thyroid disease (those who are considered to be able to participate in this trial by the tester can participate) drug or alcohol abuser If ALT(Alanine transaminase ) or AST(Aspartate transaminase) exceeds 3 times the normal upper limit of the research institute If creatinine exceeds twice the upper limit of the normal level of research institute Mammography / PAP smear If a clinically significant abnormality (Breast imaging-reporting and data system: BI-RADS 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, ) 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 If the tester judges that the test is inappropriate for this clinical trial Women using thyroid hormone preparations, clonidine, anticoagulants or antithrombotic agents (Warfarin, Clopidogrel, etc.) within 3 months Women who took medicines or health functional foods related to women's menopause within a month

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This clinical trial will be conducted in parallel with the test group or the control group randomly assigned.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPC-03<br>To experimental arm randomly assigned, HPC-03 will administrated twice a day , two capsules each time (total dose of HPC-03: 2g/day) for 12 weeks (84days). *(HPC-03: extracts of angelica gigas nakai, cnidium rhizome, and cinnamon bark.) | Dietary Supplement: HPC-03<br>* HPC-03 is extracts of danggui (angelica gigas nakai), taeunggung (cnidium rhizome), and broilers (cinnamon bark).<br>* Other names: angelica gigas nakai, cnidium rhizome, and cinnamon bark;|
| Placebo Comparator: Placebo<br>To control arm randomly assigned, placebo will administrated twice a day , two capsules each time for 12 weeks (84days). | Dietary Supplement: Placebo<br>* Placebo is constituted of crystalline cellulose(50.5%), corn starch(33.10%), caramel color(1.90%), anhydrous citric acid(1.25%), silicon dioxide(1.90%), carboxymethylcellulose calcium(6.25%), magnesium stearate(2.50%), and coater (3.10%).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Modified Kupperman Index score at 6 weeks and 12 weeks |  | At baseline, 6weeks and 12 weeks after administration of HPC-03 or placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endometrial thickness measured by transvaginal ultrasonography |  | At baseline and 12 weeks after administration of HPC-03 | 
| serum estradiol (E2) |  | At baseline and 12 weeks after administration of HPC-03 or placebo | 
| serum FSH (Follicular stimulating hormone) | Follicular stimulating hormone | At baseline and 12 weeks after administration of HPC-03 or placebo |