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DyslipidemiasPhase 2/3NCT06220266

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

A Phase 2/3 study testing Phytoestrogen in people with Dyslipidemias and Hypertriglyceridemia, run by Dhurakij Pundit University at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
What is being tested?
Phytoestrogen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
1 siteThailand
Study dates
2 Mar 2024to Nov 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Natural menopause, last menstrual period more than one year ago.
  • 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)
  • Willing to participate in the project

Who cannot join

  • Have ever received lipid-lowering medication or hormone replacement therapy or SERMs. During the past 6 weeks
  • have had surgery on the ovaries or uterus before
  • have a history of cancer within a 5-year period
  • have diabetes or uncontrolled high blood pressure, including HbA1c >9, Systolic blood pressure >180 or Diastolic blood pressure >110
  • Endocrine system disease such as thyroid
  • Ever had an organ transplant
Show all 10Show fewer
  • Regularly use drugs, marijuana, or drink alcohol.
  • has a psychiatric disorder
  • have other serious medical conditions that require close monitoring
  • Inconvenient to follow up until the end of the research.

Trial locations and contacts

1 site in 1 country.

Prischa Saengow, MD. contact

+66-65-2162299

purnprattana@gmail.com

Thailand1 site, 1 recruiting

  • Dhurakij Pundit University

    Laksi, Bangkok, 10210

    P Jan Pitchapat, 02-9547300 dial 853, antiaging@dpu.ac.th

    Recruiting

Other trials in Thailand

About this study

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
Being tested
Phytoestrogen, Diet control & life style modification
Keywords
Phytoestrogens, Pueraria Mirifica, Postmenopausal women, Dyslipidemia, Hypertriglyceridemia, Hypercholesterolemia, Hyper-LDL-cholesterolemia, Hypo HDL Cholesterolaemia, Postmenopausal Symptoms, Randomized clinical trail
Medical subject headings
Dyslipidemias, Hypertriglyceridemia, Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PhytoestrogenDrug

    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

  • Diet control & life style modificationDrug

    Diet control \& life style modification

Study groups in NCT06220266
Study groupRoleWhat they receive
Diet control & life style modificationPlacebo comparatorDiet control \& life style modification
Receives: Drug: Diet control & life style modification
PMExperimentalPueraria mirifica
Receives: Drug: Phytoestrogen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum lipid parameters

    serum triglyceride, total cholesterol, LDL, HDL

    Measured: 2 months

Secondary outcomes (6)

  1. Menopause symptom score

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

    Measured: 2 months

  2. Blood Pressure

    mmHg

    Measured: 2 months

  3. Body mass index(BMI) or body weight

    Measured: 2 months

  4. waist circumference

    cm

    Measured: 2 months

  5. kidney function

    Creatinine, BUN, eGFR

    Measured: 2 months

  6. liver enzymes

    AST, ALT

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2024
  2. Study start2 Mar 2024
  3. Primary completionAug 2024 (estimated)
  4. Study completionNov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Patient preference trial
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06220266
Sponsor's protocol ID
DPUHREC010/66FB
Status last verified
May 2024
First submitted
14 Jan 2024
Last updated
24 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Not sure yet whether it is possible to share but plan to up load all the record form and lab investigation if possible

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).

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Phytoestrogen in people with Dyslipidemias and Hypertriglyceridemia, run by Dhurakij Pundit University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Prischa Saengow, MD. (+66-65-2162299, purnprattana@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum lipid parameters (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06220266, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.

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