Composition for Treating Uterine Fibroid (SB-UF) (SB-UF)

June 5, 2026 updated by: Trieu, Nguyen Thi, M.D.

Uterine Fibroids Are a Prevalent Finding in Women of Reproductive Age. Ready Safety Study Extracts of Plants Pregnenolone, Pyridoxal Phosphate, and Dydrogesterone for Treating Uterine Fibroids in Women's Pregnancy.

Pregnenolone & Pyridoxal Phosphate SB-UF for treating uterine fibroids in women's pregnancies to lose the size of fibroids and to dissolve fibroids.

Uterine fibroids are a very common finding in women pregnancy of reproductive age, fibroids fast grow in the first trimester of pregnancy. SB-UF against the rapid growth of fibroids under the influence of hormones during pregnancy. Use SB-UF to think about regulating stable Oestrogen levels and dissolving fibroids.

This is a substantial insight into disease pathogenesis, with a clear path toward clinical application, which would lead to a substantial advance and perfection in management or public health policy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Uterine fibroids are a very common finding in women's pregnancy of reproductive age fibroids fast grow in the first trimester of pregnancy.

Clinically has shown that:

  • Uterine fibroids are associated with heavy or prolonged menstrual periods, and abnormal bleeding between menstrual periods.
  • Fibroids are associated with increased rates of spontaneous miscarriage, premature birth, placenta ablation, malpresentation, labor dysfunction, cesarean section, and postpartum hemorrhage, pain is the most common complication of fibroids uterus during pregnancy.
  • Use the composition that has sufficient Pregnenolone, and coenzyme Pyridoxal Phosphate, and combined with Dydrogesterone, this preparation will soften uterine fibroids and disappear fibroids.

Pregnenolone is produced in the adrenal glands and the central nervous system. Pregnenolone is synthesized from Cholesterol and it is the precursor of Progesterone, Estrogen, and dehydroepiandrosterone (DHEA). In some people Pregnenolone will decrease with age, which will lead to an imbalance between Progesterone and estrogen, according to research, this imbalance is the cause of abnormal growth of the uterine muscle fibers cells that produce multiple fibroids in the womb. Supplementation Pregnenolone is necessary for women of childbearing and reproductive age, overtime tracking pregnant women but there were fibroids from before pregnancy these fibroids will develop very quickly to stun the fetus many problems in pregnancy, and childbirth, the risk of miscarriage, preterm delivery,...The new drug will maintain a sufficient amount of Pregnenolone natural is the essence from Dioscorea persimilis prain & burkill and associated with a necessary element is Coenzyme Pyridoxal Phosphate, Dydrogesterone. Compound presence in the body will curb the development of the muscle fibers uterus, the muscle fibers in the fibroids will soften, spread out, and disappear fibroids. The uterus returns to its normal state, the fetus will develop naturally.

Research results

  • After 40 weeks of ultrasound examination:

    • 100% of women using SB-UF drugs have the disappearance of fibroids, only the image of uterine muscle is thicker than usual.
    • 100% of women who received SB-UF placebo did not experience any beneficial progress.
  • Through study completion, an average of 40 weeks

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam, 700000
        • Saigon Biopharma Company Limited

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Procedure to the treatment of fibroids in pregnancy and in women desiring future fertility.

Exclusion Criteria:

  • Subserosal fibroids may be pedunculated hanging from a stalk inside or outside the uterus.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SB-UF Drug
Use SB-UF drugs to lose the size of Uterine Fibroids on Women the Pregnancy. Measuring the size of uterine fibroid. Monitor the disappearance of uterine fibroids from 4 - 40 weeks
Drug: SB-UF

Dosage:

-Take 1tablet/2 times/day/in throughout pregnancy.

Other Names:
  • Pregnenolone 60mg & Pyridoxal Phosphate 20mg & Dydrogesterone 10mg & Impatien balsamina extract 100 mg
Placebo Comparator: SB-UF Placebo
Use SB-UF placebo to lose the size of Uterine Fibroids on Women the Pregnancy. Measuring the size of uterine fibroid. Monitor the disappearance of uterine fibroids from 4 - 40 weeks
Device: SB-UF Placebo

Dosage:

-Take 1tablet/2 times/day/in throughout pregnancy.

Other Names:
  • Pregnenolone & Pyridoxal Phosphate Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use SB-UF drugs to lose the size of Uterine Fibroids on Women the Pregnancy.
Time Frame: 40 weeks
Measuring the size of uterine fibroid. Monitor the disappearance of benign smooth muscle cell tumors of the uterus
40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trieu, Nguyen Thi, M.D.

Collaborators

TRAN MINH DUC, MD

Investigators

  • Principal Investigator: Thi Trieu Nguyen, Dr., Trieu, Nguyen Thi, M.D.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

January 3, 2021

First Submitted That Met QC Criteria

February 18, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Removal the Uterine Fibroids

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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