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

Dhurakij Pundit University

Status and phase: Enrolling; Phase 3; Phase 2

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

Treatments: Drug: Phytoestrogen; Drug: Diet control & life style modification

Study type: Interventional

Funder types: Other

Identifiers

NCT06220266

DPUHREC010/66FB

Details and patient eligibility

About

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

Full 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

Enrollment: 10 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups, including a placebo group

Diet control & life style modification

Placebo Comparator group

Description:

Diet control \& life style modification

Treatment:

Drug: Diet control & life style modification

PM

Experimental group

Description:

Pueraria mirifica

Treatment:

Drug: Phytoestrogen