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RecruitingNCT06220266Updated May 24, 2024

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

A Phase 2/3 interventional study of Phytoestrogen and Diet control & life style modification in Dyslipidemias, Hypertriglyceridemia and Hypercholesterolemia, sponsored by Dhurakij Pundit University. Recruiting at 1 site in Thailand. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-24.

Sponsored by Dhurakij Pundit University · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 8 months later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Sex
Female
01

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

Read the 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
02

Conditions studied

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

Keywords

  • Phytoestrogens
  • Pueraria Mirifica
  • Postmenopausal women
  • Dyslipidemia
  • Hypertriglyceridemia
  • Hypercholesterolemia
  • Hyper-LDL-cholesterolemia
  • Hypo HDL Cholesterolaemia
  • Postmenopausal Symptoms
  • Randomized clinical trail
03

In context

Dyslipidemias

1,247 studies on the registry are indexed under Dyslipidemias; 175 are open to participants now.

This study's planned enrollment of 10 is below the median of 100 across 986 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Dhurakij Pundit University is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 >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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Placebo comparator
    Diet control & life style modification

    Diet control \& life style modification

    Drug: Diet control & life style modification

  • Experimental
    PM

    Pueraria mirifica

    Drug: Phytoestrogen

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

06

What researchers measure

Primary outcomes

  1. Serum lipid parameters

    serum triglyceride, total cholesterol, LDL, HDL

    Time frame: 2 months

Secondary outcomes

  1. Menopause symptom score

    Greene Climacteric Scale(GCS) minimum values= 0 , maximum values=63 , higher scores mean higher menopause symptom(worse outcome).

    Time frame: 2 months

  2. Blood Pressure

    mmHg

    Time frame: 2 months

  3. Body mass index(BMI) or body weight

    Time frame: 2 months

  4. waist circumference

    cm

    Time frame: 2 months

  5. kidney function

    Creatinine, BUN, eGFR

    Time frame: 2 months

  6. liver enzymes

    AST, ALT

    Time frame: 2 months

07

Study locations

1 of 1 sites recruiting
  • Dhurakij Pundit University
    Laksi, Bangkok 10210, Thailand
    Recruiting
08

References and documents

Publications

  • [1] World Health Organization . Geneva: World Health Organization; c2019. Global Health Observatory (GHO) data [Internet] [cited 2019 Jun 20]. Available from: http://www.who.int/gho/ncd/mortality_morbidity/ncd_total/en/index.html. [Google Scholar] [2] World Health Organization . Geneva: World Health Organization; c2019. Preventing chronic diseases: a vital investment [Internet] [cited 2019 Jun 20]. Available from: http://www.who.int/chp/chronic_disease_report/en. [Google Scholar] [3] Rhee EJ, Kim HC, Kim JH, et al. 2018 Guidelines for the management of dyslipidemia [published correction appears in Korean J Intern Med. 2019 Sep;34(5):1171]. Korean J Intern Med. 2019;34(4):723-771. doi:10.3904/kjim.2019.188 [4] Xi Y, Niu L, Cao N, et al. Prevalence of dyslipidemia and associated risk factors among adults aged ≥35 years in northern China: a cross-sectional study. BMC Public Health. 2020;20(1):1068. Published 2020 Jul 6. doi:10.1186/s12889-020-09172-9 [5] Ambikairajah, Ananthan BSc, MTeach, PhDc; Walsh, Erin PhD; Cherbuin, Nicolas PhD. Lipid profile differences during menopause: a review with meta-analysis. Menopause 26(11):p 1327-1333, November 2019. DOI: 10.1097/GME.0000000000001403 [6] Liang J, & Shang Y (2013). Estrogen and cancer. Annu Rev Physiol, 75, 225-240. [7] Blaustein JD 2008 An estrogen by any other name. Endocrinology 149:2697-2698 [8] Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA.2002;288:321-333. [9] Sookvanichsilp N, Soonthornchareonnon N, Boonleang C. Estrogenic activity of the dichloromethane extract from Pueraria mirifica. Fitoterapia. 2008 Dec;79(7-8):509-14. doi: 10.1016/j.fitote.2008.05.006. Epub 2008 Jun 22. PMID: 18621111. [10] Peacock K, Ketvertis KM. Menopause. [Updated 2022 Aug 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK507826/ [11] Pappan N, Rehman A. Dyslipidemia. [Updated 2022 Jul 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK560891/ [12] Menazza S, Murphy E. The Expanding Complexity of Estrogen Receptor Signaling in the Cardiovascular System. Circ Res. 2016 Mar 18;118(6):994-1007. doi: 10.1161/CIRCRESAHA.115.305376. Epub 2016 Jan 7. PMID: 26838792; PMCID: PMC5012719. [13] Rossella E Nappi, et al. Menopause: a cardiometabolic transition. Lancet Diabetes Endocrinol. 2022 Jun;10(6):442-456. doi: 10.1016/S2213-8587(22)00076-6. [14] Hester M. den Ruijter, Georgios Kararigas. Estrogen and Cardiovascular Health. Front. Cardiovasc. Med., 2022 March 30:9 Sec. Sex and Gender in Cardiovascular Medicinehttps://doi.org/10.3389/fcvm.2022.886592 [15] Moskowitz D. A comprehensive review of the safety and efficacy of bioidentical hormones for the management of menopause and related health risks. Altern Med Rev. 2006 Sep;11(3):208-23. PMID: 17217322. [16] Holtorf K. The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy? Postgrad Med. 2009 Jan;121(1):73-85. doi: 10.3810/pgm.2009.01.1949. PMID: 19179815. [17] Howlader N, Altekruse SF, Li CI, Chen VW, Clarke CA, Ries LA, et al. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst. 2014;106:dju055 [18] WHO launches new roadmap on breast cancer. World Health Organization. Updated at February 3, 2023. Access September 9, 2023. https://www.who.int/news/item/03-02-2023-who-launches-new-roadmap-on-breast-cancer [19] Yue W, Wang JP, Li Y, Fan P, Liu G, Zhang N, Conaway M, Wang H, Korach KS, Bocchinfuso W, Santen R. Effects of estrogen on breast cancer development: Role of estrogen receptor independent mechanisms. Int J Cancer. 2010 Oct 15;127(8):1748-57. doi: 10.1002/ijc.25207. PMID: 20104523; PMCID: PMC4775086. [20] Martinkovich, Stephen & Shah, Darshan & Lobo, Sonia & Arnott, John. (2014). Selective estrogen receptor modulators: Tissue specificity and clinical utility. Clinical Interventions in Aging. 4. 1437. 10.2147/CIA.S66690. [21] Pickar JH, Komm BS (Sep 2015).

Individual participant data

Plan to share: Undecided — Not sure yet whether it is possible to share but plan to up load all the record form and lab investigation if possible

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2024 (actual). Primary completion is estimated for Aug 2024, 5 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2024
First posted
Jan 23, 2024
StartActual
Mar 2, 2024
Primary completionEst.
Aug 2024
CompletionEst.
Nov 2024
Last update
May 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06220266
Lead sponsor
Dhurakij Pundit University
Responsible party
Prischa Saengow (medical doctor, Dhurakij Pundit University) — Principal investigator
First posted
Jan 23, 2024
Start date
Mar 2, 2024
Primary completion
Aug 2024 (estimated)
Completion
Nov 2024 (estimated)
Last update
May 24, 2024

Study contacts

Prischa Saengow, MD.
Contact
purnprattana@gmail.com
+66-65-2162299
Prischa Saengow, MD.
principal investigator · Dhurakij Pundit University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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