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

Last updated: May 23, 2024
Sponsor: Dhurakij Pundit University
Overall Status: Active - Recruiting

Phase

2/3

Condition

Hypercholesterolemia

Hypertriglyceridemia

Treatment

Diet control & life style modification

Phytoestrogen

Placebo

Clinical Study ID

NCT06220266
DPUHREC010/66FB
  • Female
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

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)

  1. Willing to participate in the project

Exclusion

Exclusion Criteria:

  1. Have ever received lipid-lowering medication or hormone replacement therapy orSERMs. 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, Systolicblood 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

Total Participants: 10
Treatment Group(s): 3
Primary Treatment: Diet control & life style modification
Phase: 2/3
Study Start date:
March 02, 2024
Estimated Completion Date:
November 30, 2024

Study 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

Connect with a study center

  • Dhurakij Pundit University

    Laksi, Bangkok 10210
    Thailand

    Active - Recruiting

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