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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-02

Study Completion Date

2024-11-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Dyslipidemias Hypertriglyceridemia Hypercholesterolemia Hyper-LDL-cholesterolemia Hypo HDL Cholesterolaemia Postmenopausal Symptoms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Patient preference trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Unmasked due to patient preference trial

Study Groups

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Diet control & life style modification

Diet control \& life style modification

Group Type PLACEBO_COMPARATOR

Diet control & life style modification

Intervention Type DRUG

Diet control \& life style modification

PM

Pueraria mirifica

Group Type EXPERIMENTAL

Phytoestrogen

Intervention Type DRUG

consume 1 capsule twice a day for 2 months which one capsule composed of dry weight 50 mg of Pueraria Mirifica 1or Pueraria Mirifica 2 or Pueraria Mirifica 3

Interventions

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Phytoestrogen

consume 1 capsule twice a day for 2 months which one capsule composed of dry weight 50 mg of Pueraria Mirifica 1or Pueraria Mirifica 2 or Pueraria Mirifica 3

Intervention Type DRUG

Diet control & life style modification

Diet control \& life style modification

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes