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Efficacy and Safety of HPC-03 for Postmenopausal Symptom

Sponsor
Jae Hoon Lee (Other)
Overall Status
Unknown status
CT.gov ID
NCT03061799
Collaborator
Gachon University Gil Medical Center (Other), Daejeon University (Other)
150
Enrollment
1
Location
2
Arms
11
Anticipated Duration (Months)
13.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: HPC-03
  • Dietary Supplement: Placebo
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This clinical trial will be conducted in parallel with the test group or the control group randomly assigned.This clinical trial will be conducted in parallel with the test group or the control group randomly assigned.
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of HPC-03(Extracts of Angelica Gigas Nakai, Cnidium Rhizome, and Cinnamon Bark) for Postmenopausal Symptom
Actual Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
May 1, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

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%).

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. endometrial thickness measured by transvaginal ultrasonography [At baseline and 12 weeks after administration of HPC-03]

    2. serum estradiol (E2) [At baseline and 12 weeks after administration of HPC-03 or placebo]

    3. serum FSH (Follicular stimulating hormone) [At baseline and 12 weeks after administration of HPC-03 or placebo]

      Follicular stimulating hormone

    Other Outcome Measures

    1. serum alkaline phosphatase [At screening and 6weeks and 12 weeks after administration of HPC-03 or placebo]

    2. serum osteocalcin [At baseline and 6weeks and 12 weeks after administration of HPC-03 or placebo]

    3. Urine N-terminal cross-linker telopeptidase [At baseline, 6weeks and 12 weeks after administration of HPC-03 or placebo]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Severance hospital, Yonsei University College of Medicine Seoul Korea, Republic of 03722

    Sponsors and Collaborators

    • Jae Hoon Lee
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jae Hoon Lee, Cinical Fellow, Severance Hospital
    ClinicalTrials.gov Identifier:
    NCT03061799
    Other Study ID Numbers:
    • 4-2016-0680
    First Posted:
    Feb 23, 2017
    Last Update Posted:
    Feb 23, 2017
    Last Verified:
    Feb 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Feb 23, 2017