Efficacy and Safety of HPC-03 for Postmenopausal Symptom

February 19, 2017 updated by: Jae Hoon Lee

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital, Yonsei University College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HPC-03

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
HPC-03 is extracts of danggui (angelica gigas nakai), taeunggung (cnidium rhizome), and broilers (cinnamon bark).
Other Names:
  • angelica gigas nakai, cnidium rhizome, and cinnamon bark
PLACEBO_COMPARATOR: Placebo
To control arm randomly assigned, placebo will administrated twice a day , two capsules each time for 12 weeks (84days).
Dietary supplement: 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%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline Modified Kupperman Index score at 6 weeks and 12 weeks
Time Frame: At baseline, 6weeks and 12 weeks after administration of HPC-03 or placebo
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
Time Frame: At baseline and 12 weeks after administration of HPC-03
At baseline and 12 weeks after administration of HPC-03
serum estradiol (E2)
Time Frame: At baseline and 12 weeks after administration of HPC-03 or placebo
At baseline and 12 weeks after administration of HPC-03 or placebo
serum FSH (Follicular stimulating hormone)
Time Frame: At baseline and 12 weeks after administration of HPC-03 or placebo
Follicular stimulating hormone
At baseline and 12 weeks after administration of HPC-03 or placebo

Other Outcome Measures

Outcome Measure
Time Frame
serum alkaline phosphatase
Time Frame: At screening and 6weeks and 12 weeks after administration of HPC-03 or placebo
At screening and 6weeks and 12 weeks after administration of HPC-03 or placebo
serum osteocalcin
Time Frame: At baseline and 6weeks and 12 weeks after administration of HPC-03 or placebo
At baseline and 6weeks and 12 weeks after administration of HPC-03 or placebo
Urine N-terminal cross-linker telopeptidase
Time Frame: At baseline, 6weeks and 12 weeks after administration of HPC-03 or placebo
At baseline, 6weeks and 12 weeks after administration of HPC-03 or placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jae Hoon Lee

Collaborators

Gachon University Gil Medical Center
Daejeon University

Investigators

  • Study Director: Seok Kyo Seo, M.D., Ph.D., Department of Obstetrics and Gynecology, Yonsei University College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ANTICIPATED)

May 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

January 22, 2017

First Submitted That Met QC Criteria

February 19, 2017

First Posted (ACTUAL)

February 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 19, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 4-2016-0680

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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