Efficacy and Safety of HPC-03 for Postmenopausal Symptom

Postmenopausal Period Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03061799
• Other study ID #: 4-2016-0680
• Status: Recruiting
• Phase: N/A
• First received: January 22, 2017
• Last updated: February 19, 2017
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: February 2017
• Source: Severance Hospital
• Contact: Jae Hoon Lee, M.D.
• Phone: +82-10-9985-4676
• Email: jhlee126[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Postmenopausal Period

Intervention

Dietary Supplement:
• HPC-03
HPC-03 is extracts of danggui (angelica gigas nakai), taeunggung (cnidium rhizome), and broilers (cinnamon bark).
• Placebo
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%).

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital, Yonsei University College of Medicine	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Jae Hoon Lee	Dunsan Korean Medicine Hospital of Daejeon University, Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	serum alkaline phosphatase		At screening and 6weeks and 12 weeks after administration of HPC-03 or placebo
Other	serum osteocalcin		At baseline and 6weeks and 12 weeks after administration of HPC-03 or placebo
Other	Urine N-terminal cross-linker telopeptidase		At baseline, 6weeks and 12 weeks after administration of HPC-03 or placebo
Primary	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	endometrial thickness measured by transvaginal ultrasonography		At baseline and 12 weeks after administration of HPC-03
Secondary	serum estradiol (E2)		At baseline and 12 weeks after administration of HPC-03 or placebo
Secondary	serum FSH (Follicular stimulating hormone)	Follicular stimulating hormone	At baseline and 12 weeks after administration of HPC-03 or placebo