Effects of Phytoestrogen From Pueraria Mirifica in Improvement of Serum Lipid Parameters in Postmenopausal Women

Phase 3RecruitingNCT06220266

Dhurakij Pundit University10 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dyslipidemias Hypertriglyceridemia

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Serum lipid parameters

serum triglyceride, total cholesterol, LDL, HDL

Time frame: 2 months

Secondary Outcomes

Menopause symptom score

Greene Climacteric Scale(GCS) minimum values= 0 , maximum values=63 , higher scores mean higher menopause symptom(worse outcome).

Time frame: 2 months

Blood Pressure

mmHg

Time frame: 2 months

Body mass index(BMI) or body weight

Time frame: 2 months

waist circumference

Time frame: 2 months

kidney function

Creatinine, BUN, eGFR

Time frame: 2 months

liver enzymes

AST, ALT

Time frame: 2 months

Effects of Phytoestrogen From Pueraria Mirifica in Improvement of Serum Lipid Parameters in Postmenopausal Women

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts