NCT03061799

Efficacy and Safety of HPC-03 for Postmenopausal Symptom

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Jae Hoon Lee · Academic / Other
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Postmenopausal Period

Interventions

Type	Name	Description
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%).

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-05-01
• Completion: 2017-12-01
• First posted: 2017-02-23
• Last updated: 2017-02-23

Locations

1 site across 1 country: South Korea