Clinical trial NCT03061799: Efficacy and Safety of HPC-03 for Postmenopausal Symptom
Official title: Efficacy and Safety of HPC-03(Extracts of Angelica Gigas Nakai, Cnidium Rhizome, and Cinnamon Bark) for Postmenopausal Symptom
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postmenopausal Period
Lead sponsor: Severance Hospital
Sponsor class: OTHER
Collaborators: name: Gachon University Gil Medical Center
name: Daejeon University
First posted: 2017-02-23
Enrollment: 150
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This clinical trial will be conducted in parallel with the test group or the control group randomly assigned.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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:

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 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, )
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

Primary outcomes:
measure: Change from baseline Modified Kupperman Index score at 6 weeks and 12 weeks
timeFrame: At baseline, 6weeks and 12 weeks after administration of HPC-03 or placebo
Secondary outcomes:
measure: endometrial thickness measured by transvaginal ultrasonography
timeFrame: At baseline and 12 weeks after administration of HPC-03
measure: serum estradiol (E2)
timeFrame: At baseline and 12 weeks after administration of HPC-03 or placebo
measure: serum FSH (Follicular stimulating hormone)
timeFrame: At baseline and 12 weeks after administration of HPC-03 or placebo
Other outcomes:
measure: serum alkaline phosphatase
timeFrame: At screening and 6weeks and 12 weeks after administration of HPC-03 or placebo
measure: serum osteocalcin
timeFrame: At baseline and 6weeks and 12 weeks after administration of HPC-03 or placebo
measure: Urine N-terminal cross-linker telopeptidase
timeFrame: At baseline, 6weeks and 12 weeks after administration of HPC-03 or placebo
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital, Yonsei University College of Medicine
Study officials:
affiliation: Department of Obstetrics and Gynecology, Yonsei University College of Medicine
name: Seok Kyo Seo, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.