Clinical trial NCT06220266: Effects of Phytoestrogen From Pueraria Mirifica in Improvement of Serum Lipid Parameters in Postmenopausal Women
Official title: Effects of Phytoestrogen From Pueraria Mirifica in Improvement of Serum Lipid Parameters in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Dyslipidemias
Hypertriglyceridemia
Hypercholesterolemia
Hyper-LDL-cholesterolemia
Hypo HDL Cholesterolaemia
Postmenopausal Symptoms
Keywords: Phytoestrogens
Pueraria Mirifica
Postmenopausal women
Dyslipidemia
Hypertriglyceridemia
Hypercholesterolemia
Hyper-LDL-cholesterolemia
Hypo HDL Cholesterolaemia
Postmenopausal Symptoms
Randomized clinical trail
Lead sponsor: Dhurakij Pundit University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 10
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient preference trial
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

1. Natural menopause, last menstrual period more than one year ago.
2. 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)
3. Willing to participate in the project

Exclusion Criteria:

1. Have ever received lipid-lowering medication or hormone replacement therapy or SERMs. During the past 6 weeks
2. have had surgery on the ovaries or uterus before
3. have a history of cancer within a 5-year period
4. have diabetes or uncontrolled high blood pressure, including HbA1c \>9, Systolic blood pressure \>180 or Diastolic blood pressure \>110
5. Endocrine system disease such as thyroid
6. Ever had an organ transplant
7. Regularly use drugs, marijuana, or drink alcohol.
8. has a psychiatric disorder
9. have other serious medical conditions that require close monitoring
10. Inconvenient to follow up until the end of the research.

Primary outcomes:
measure: Serum lipid parameters
timeFrame: 2 months
Secondary outcomes:
measure: Menopause symptom score
timeFrame: 2 months
measure: Blood Pressure
timeFrame: 2 months
measure: Body mass index(BMI) or body weight
timeFrame: 2 months
measure: waist circumference
timeFrame: 2 months
measure: kidney function
timeFrame: 2 months
measure: liver enzymes
timeFrame: 2 months
Other outcomes:
Locations:
city: Laksi
country: Thailand
facility: Dhurakij Pundit University
state: Bangkok
Study officials:
affiliation: Dhurakij Pundit University
name: Prischa Saengow, MD.
role: PRINCIPAL_INVESTIGATOR
References:
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