Efficacy and Safety of HPC-03(Extracts of Angelica Gigas Nakai, Cnidium Rhizome, and Cinnamon Bark) for Postmenopausal Symptom
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change from baseline Modified Kupperman Index score at 6 weeks and 12 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from baseline Modified Kupperman Index score at 6 weeks and 12 weeks
时间窗: At baseline, 6weeks and 12 weeks after administration of HPC-03 or placebo
次要结局
- endometrial thickness measured by transvaginal ultrasonography(At baseline and 12 weeks after administration of HPC-03)
- serum FSH (Follicular stimulating hormone)(At baseline and 12 weeks after administration of HPC-03 or placebo)
- serum estradiol (E2)(At baseline and 12 weeks after administration of HPC-03 or placebo)
研究者
Jae Hoon Lee
Cinical Fellow
Severance Hospital