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

Phase 2

Recruiting

• Conditions: Dyslipidemias; Hypertriglyceridemia; Hyper-LDL-cholesterolemia; Hypercholesterolemia; Postmenopausal Symptoms; Hypo HDL Cholesterolaemia
• Interventions: Drug: Diet control & life style modification; Drug: Phytoestrogen

• Registration Number: NCT06220266
• Lead Sponsor: Dhurakij Pundit University

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

Study Timeline

• Study First Submitted: 2024-01-14
• Study First Submitted QC: 2024-01-14
• Study First Posted: 2024-01-23
• Study Start: 2024-03-02
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24
• Primary Completion: 2024-08
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet control & life style modification	Diet control & life style modification	Diet control \& life style modification
PM	Phytoestrogen	Pueraria mirifica

Primary Outcome Measures

Name	Time	Method
Serum lipid parameters	2 months	serum triglyceride, total cholesterol, LDL, HDL

Secondary Outcome Measures

Name	Time	Method
Blood Pressure	2 months	mmHg
Body mass index(BMI) or body weight	2 months
Menopause symptom score	2 months	Greene Climacteric Scale(GCS) minimum values= 0 , maximum values=63 , higher scores mean higher menopause symptom(worse outcome).
liver enzymes	2 months	AST, ALT
waist circumference	2 months	cm
kidney function	2 months	Creatinine, BUN, eGFR

Trial Locations

Locations (1)

Dhurakij Pundit University; 🇹🇭 Laksi, Bangkok, Thailand