Dyslipidemias, Hypercholesterolemia, Hyper-LDL-cholesterolemia, Hypertriglyceridemia, Hypo HDL Cholesterolaemia, Postmenopausal Symptoms
Conditions
Keywords
Phytoestrogens, Pueraria Mirifica, Postmenopausal women, Dyslipidemia, Hypertriglyceridemia, Hypercholesterolemia, Hyper-LDL-cholesterolemia, Hypo HDL Cholesterolaemia, Postmenopausal Symptoms, Randomized clinical trail
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
Interventions
DRUGPhytoestrogen
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
DRUGDiet control & life style modification
Diet control & life style modification
Sponsors
Dhurakij Pundit University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Unmasked due to patient preference trial
Intervention model description
Patient preference trial
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum lipid parameters | 2 months | serum triglyceride, total cholesterol, LDL, HDL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| liver enzymes | 2 months | AST, ALT |
| Menopause symptom score | 2 months | Greene Climacteric Scale(GCS) minimum values= 0 , maximum values=63 , higher scores mean higher menopause symptom(worse outcome). |
| kidney function | 2 months | Creatinine, BUN, eGFR |
| Body mass index(BMI) or body weight | 2 months | — |
| waist circumference | 2 months | cm |
| Blood Pressure | 2 months | mmHg |
Countries
Thailand
Contacts
Primary ContactPrischa Saengow, MD.
Outcome results
None listed