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| Name | Class |
|---|---|
| Gachon University Gil Medical Center | OTHER |
| Daejeon University | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPC-03 | Experimental | 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.) |
|
| Placebo | Placebo Comparator | To control arm randomly assigned, placebo will administrated twice a day , two capsules each time for 12 weeks (84days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPC-03 | Dietary Supplement | HPC-03 is extracts of danggui (angelica gigas nakai), taeunggung (cnidium rhizome), and broilers (cinnamon bark). |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| serum alkaline phosphatase | At screening and 6weeks and 12 weeks after administration of HPC-03 or placebo | |
| serum osteocalcin | At baseline and 6weeks and 12 weeks after administration of HPC-03 or placebo |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jae Hoon Lee, M.D. | Contact | +82-10-9985-4676 | jhlee126@yuhs.ac | |
| Jisun Yun, M.D. | Contact | +82-10-2622-5664 | grimoire@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Seok Kyo Seo, M.D., Ph.D. | Department of Obstetrics and Gynecology, Yonsei University College of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance hospital, Yonsei University College of Medicine | Recruiting | Seoul | 03722 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22027944 | Result | Kim SY, Seo SK, Choi YM, Jeon YE, Lim KJ, Cho S, Choi YS, Lee BS. Effects of red ginseng supplementation on menopausal symptoms and cardiovascular risk factors in postmenopausal women: a double-blind randomized controlled trial. Menopause. 2012 Apr;19(4):461-6. doi: 10.1097/gme.0b013e3182325e4b. |
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This clinical trial will be conducted in parallel with the test group or the control group randomly assigned.
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The product manufactured as clinical food and placebo are identical in shape, color and weight. In addition, clinical trial food should be labeled by affixing the same label with placebo so that it remains blind to both subjects and the investigator. Lot number of the label, includes reference number of the test food and reference number of the placebo together.
Dispensing of food and placebo for clinical trials is handled by the management pharmacist.
Clinical tester supplies clinical trial food corresponding the random assignment code assigned to subjects. Except inevitable cases such as occurrence of adverse events resulted by clinical food, the code will not be released until the end of the clinical trial. In case of deficiency or breakage of food for clinical trial, extra clinical food with unique code will provided to subjects, therefore maintain blinding.
| Placebo | Dietary Supplement | 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%). |
|
| serum FSH (Follicular stimulating hormone) | Follicular stimulating hormone | At baseline and 12 weeks after administration of HPC-03 or placebo |
| Urine N-terminal cross-linker telopeptidase | At baseline, 6weeks and 12 weeks after administration of HPC-03 or placebo |