Effects of Phytoestrogen From Pueraria Mirifica in Improvement of Serum Lipid Parameters in Postmenopausal Women
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Serum lipid parameters
研究概览
简要总结
The goal of this clinical trial is to learn about the effects of phytoestrogen from Pueraria Mirifica in improvement of serum lipid parameters. The primary question it aims to answer are:
• phytoestrogen from Pueraria Mirifica can reduce serum triglyceride, total cholesterol, LDL and increase HDL or not
Participants will receive capsules which composed of dry weight 50 mg of Pueraria Mirifica twice a day for 2 months. Researchers will compare with diet control&life style modification to see if there is the improvement of serum lipid parameters
详细描述
The secondary question it aims to answer are:
- phytoestrogen from Pueraria Mirifica can reduce menopausal symptom score or not
- phytoestrogen from Pueraria Mirifica can reduce body mass index(BMI) or not
- phytoestrogen from Pueraria Mirifica can reduce waist circumference or not
- phytoestrogen from Pueraria Mirifica can reduce blood pressure or not
- phytoestrogen from Pueraria Mirifica effects to creatinine, BUN, eGFR or not
- phytoestrogen from Pueraria Mirifica effects liver function enzymes or not
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Unmasked due to patient preference trial
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Natural menopause, last menstrual period more than one year ago.
- •Abnormal lipid profile parameters The criteria set for this research are:
- •LDL>130 mg/Dl or
- •TG>150 mg/Dl or
- •Total cholesterol>200 mg/Dl or
- •HDL-C less than 50 mg/Dl. (Latest blood results not more than 6 months)
- •Willing to participate in the project
排除标准
- •Have ever received lipid-lowering medication or hormone replacement therapy or SERMs. During the past 6 weeks
- •have had surgery on the ovaries or uterus before
- •have a history of cancer within a 5-year period
- •have diabetes or uncontrolled high blood pressure, including HbA1c >9, Systolic blood pressure >180 or Diastolic blood pressure >110
- •Endocrine system disease such as thyroid
- •Ever had an organ transplant
- •Regularly use drugs, marijuana, or drink alcohol.
- •has a psychiatric disorder
- •have other serious medical conditions that require close monitoring
- •Inconvenient to follow up until the end of the research.
研究组 & 干预措施
PM
Pueraria mirifica
干预措施: Phytoestrogen (Drug)
Diet control & life style modification
Diet control & life style modification
干预措施: Diet control & life style modification (Drug)
结局指标
主要结局
Serum lipid parameters
时间窗: 2 months
serum triglyceride, total cholesterol, LDL, HDL
次要结局
- Blood Pressure(2 months)
- Body mass index(BMI) or body weight(2 months)
- Menopause symptom score(2 months)
- liver enzymes(2 months)
- waist circumference(2 months)
- kidney function(2 months)
研究者
Prischa Saengow
medical doctor
Dhurakij Pundit University