Efficacy and safety of SGE on menopausal symptoms; A 12week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003788

Enrollment

100

Registered

2019-04-16

Start date

2017-11-29

Completion date

Unknown

Last updated

2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : The participants enrolled in this study was assigned to 2 groups by double-blinde randomization. Extract powder from germinated gemmule of bean group: Extract powder from germinat

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) 40 to 60 year-old women who have passed one year since the last menstrual period or who have FSH 30 mIU/ml without uterus 2) Kupperman Index score of 20 of more

Exclusion criteria

Exclusion criteria: 1) BMI(Body Mass Index) > 30Kg/m2 2) Hormone therapy within the past 3 months 3) Subject with severe mental illness, such as depression and anxiety disorder, or who is currently taking neuro-psychotic drugs such as antidepressants 4) When a clinically significant abnormality (BI-RADS(Breast Imaging Reporting and Data System) Category 0 or 3 or more, PAP smear(Papanicolaou smear) is normal up to ASCUS(Atypical Squamous Cell Undetermined Significance)) is confirmed from Mammography/PAP smear 5) Subject who is taking osteoporosis drugs such as Bisphosphonate

Design outcomes

Primary

Measure	Time frame
kupperman Index;Alkaline phosphatase;Osteocalcin;C-terminal telopeptide	—

Secondary

Measure	Time frame
Estradiol, Follicle stimulating hormone, Endometrial thickness	—

Countries

Korea, Republic of

Contacts

Public ContactHoon Choi

Inje University Sanggye Paik Hospital

lightspot@naver.com+82-2-950-1057

Outcome results