Composition for Treating Uterine Fibroid (SB-UF)

NCT ID: NCT04762316

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-02-01

Brief Summary

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.

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

Conditions

Uterine Fibroids Affecting Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

SB-UF

Intervention Type: DRUG

Dosage:

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

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

Group Type: PLACEBO_COMPARATOR

SB-UF Placebo

Intervention Type: DEVICE

Dosage:

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

Interventions

SB-UF

Dosage:

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

Intervention Type: DRUG

SB-UF Placebo

Dosage:

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

Intervention Type: DEVICE

Other Intervention Names

Pregnenolone 60mg & Pyridoxal Phosphate 20mg & Dydrogesterone 10mg & Impatien balsamina extract 100 mg; Pregnenolone & Pyridoxal Phosphate Placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

TRAN MINH DUC, MD

UNKNOWN

Sponsor Role: collaborator

Tran Minh Cam Tu, MD

UNKNOWN

Sponsor Role: collaborator

Trieu, Nguyen Thi, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thi Trieu Nguyen, Dr.

Role: PRINCIPAL_INVESTIGATOR

Trieu, Nguyen Thi, M.D.

Locations

Saigon Biopharma LLC

Wilmington, Delaware, United States

Saigon Biopharma Company Limited

Ho Chi Minh City, , Vietnam

Countries

United States; Vietnam

Related Links

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2876319

Contemporary Management of Fibroids in Pregnancy

http://www.mayoclinic.org/diseases-conditions/uterine-fibroids/symptoms-causes/syc-20354288

Uterine fibroids

http://patentscope.wipo.int/search/en/detail.jsf?docId=WO2020095085&_cid=P20-KJGXFA-35465-1

WO2020095085 - COMPOSITION for TREATING UTERINE FIBROIDS

Other Identifiers

Removal the Uterine Fibroids

Identifier Type: -

Identifier Source: org_study_id