A human study to evaluate safety and effectiveness of Pueraria Flos and Pericarpium Citri extract mixture on menopausal symptoms in postmenopausal women

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003335

Enrollment

Registered

2018-11-09

Start date

2018-10-29

Completion date

Unknown

Last updated

2020-05-18

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 : Pueraria Flos and Pericarpium Citri extract mixture and color-matched placebo. Each treatment group should take 3 capsules once a day, for up to 12 weeks.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) The particioants who give informed consent before the start 2) 45~60 years old 3) Postmenopause (defined as at least 12 months amenorrhoea) or Perimenopause (defined as having no more than one menstrual period during the 3 months before recruitment) women 4) Women with moderate to severe menopausal symptoms (Kupperman index total score = 15) 5) Women with an average of 10 or more daily hot flash score during the last week

Exclusion criteria

Exclusion criteria: 1) Subjects with surgical or chemotherapy induced menopause, or who have been vaginal bleeding without diagnosis 2) Subjects who received hormone therapy within 6 months before the first visit 3) Subjects who consume a healthy functional food and herbal medicine that can affect menopausal health, bone health, blood sugar, blood lipids (triglyceride, cholesterol, etc.), blood pressure, blood circulation within 1 month of first visit 4) Subjects who have taken the following medication within the first month of their first visit or who need to take it during the study period. 5) Subjects with a history of breast cancer, endometrial hyperplasia, uterine endometrial cancer, sex steroid dependent organ tumors, or who have abnormal findings on breast X-ray or pelvic ultrasonography. 6) Subjects with liver disease, kidney disease, uncontrolled hypertension (SBP> 160 mmHg or DBP> 100 mmHg), thyroid disease, diabetes, hyperlipidemia, mental illness. 7) Subjects with a history of severe migraine headache, thromboembolic disorders, cerebrovascular disorders, serious cardiovascular condition within 1 year prior to the first visit or who need to take medicines as specified in the exclusion criteria. 8) Subjects with drug addicts or alcoholics 9) Subjects who performed constant exercises at least 3 months prior to the first visit 10) Subjects with hypersensitivity to components contained in the test food or test food 11) Subjects who participated in other clinical studies within 1 month prior to the first visit 12) Subjects who were deemed inappropriate to participation in this study

Design outcomes

Primary

Measure	Time frame
Menopausal symptoms questionnaire (Kupperman Index, MENQOL)	—

Secondary

Measure	Time frame
hot flash score;biochemical index;Safety index	—

Countries

Korea, Republic of

Contacts

Public ContactJi Eon Kim

Ewha Womans University

Outcome results