KCT0003335已完成未知
A human study to evaluate safety and effectiveness of Pueraria Flos and Pericarpium Citri extract mixture on menopausal symptoms in postmenopausal women
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 45(Year) 至 60(Year)（—）
- 性别
- Female
入选标准
- •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
排除标准
- •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
研究者
相似试验
招募中
Unknown
A human study to evaluate safety and effectiveness of Perilla oil on blood flowKCT0009442Seoul National University of Science and Technology80
已完成
不适用
A human study to evaluate safety and effectiveness of Phellinus baumii extract complex on platelet aggregation response and blood flow: a randomized, double-blind, parallel, placebo-controlled studyDiseases of the circulatory systemKCT0001642Ewha Womans University72
尚未招募
Unknown
A human study to evaluate safety and effectiveness of AB2024W on body fat level and related metabolim in obese adultsEndocrine, nutritional and metabolic diseasesKCT0009711Bundang CHA General Hospital100
尚未招募
不适用
A human study to evaluate safety and effectiveness of Tetragonia tetragonoides extract on menopausal symptoms in postmenopausal womeKCT0002616Ewha Womans University Medical Center80
尚未招募
Unknown
A human study to evaluate effectiveness and safety of Chlorella alcohol extract on eye healthKCT0009418Yonsei University Health System, Severance Hospital90