A 12-week randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of HX112 on menopausal symptoms.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007932

Enrollment

120

Registered

2022-11-24

Start date

2022-04-27

Completion date

Unknown

Last updated

2023-01-10

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 : *HX112 high dose group • Main Component: HX112 345mg/tablet • Weight: 700mg/tablet • Usage and Capacity: Intake 2 tablets /time and twice a day • Intake period: 12-weeks * HX112

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Postmenopause(passed one year since the last menstrual period) woman aged between 45 and 60 years. 2) FSH > 30 mIU/mL 3) Kupperman Index score = 20 4) Woman who has agreed to participate in this study and written an informed consent

Exclusion criteria

Exclusion criteria: 1) BMI (Body Mass Index) = 30 Kg/m2 2) Woman who has used female hormones (or similar hormone products) within 3 months 3) Woman who has hasmedical history such as endometrial hyperplasia, cervical cancer, endometrial cancer, breast cancer, or estrogen dependent tumor 4) Woman who has severe migraine within the last year, thromboembolism, cerebrovascular disease, or cardiovascular disease 5) Woman who has severe mental illness, such as depression and anxiety disorder, or are currently taking psychosomatic drugs such as antidepressants 6) Woman with metrorrhagia after one year of menopause 7) Drug or alcohol abuser 8) Woman with uncontrolled thyroid disease 9) Woman with abnormal mammography/PAP smear (BI-RADS Category > 3, PAP smear > ASCUS 10) Woman who used Clonidine, anticoagulant agent(Warfarin, Aspirin, Clipidogrel within 3 months 11) Taking a medicine or health functional foods that affects menopause symptoms within 1 month 12) taking osteoporosis drugs such as bisphosphonates 13) having participated in any other clinical trials within the past 3 months 14) Woman who has abnormal laboratory tests ? AST, ALT = three times over the normal limit ? Serum Creatinine > 2.0 mg/dl 15) Woman who are judged by the investigator to be inappropriate to participate in the study due to laboratory test results and other reasons

Design outcomes

Primary

Measure	Time frame
Kupperman Index	—

Secondary

Measure	Time frame
MENQOL-K; lipid profiles;Estradiol, FSH	—

Countries

Korea, Republic of

Contacts

Public ContactEun-Soo Jung

Jeonbuk National University Hospital

esjung@jbctc.org+82-2-259-3049

Outcome results