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Efficacy and Safety of HPC-03 for Postmenopausal Symptom

NCT03061799 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-02-23

No results posted yet for this study

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.

Conditions

  • Postmenopausal Period

Interventions

DIETARY_SUPPLEMENT

HPC-03

HPC-03 is extracts of danggui (angelica gigas nakai), taeunggung (cnidium rhizome), and broilers (cinnamon bark).

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%).

Sponsors & Collaborators

  • Gachon University Gil Medical Center

    collaborator OTHER

  • Daejeon University

    collaborator OTHER

  • Jae Hoon Lee

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-05-31
Completion
2017-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03061799 on ClinicalTrials.gov