Composition for Treating Uterine Fibroid (PP6)

Uterine Fibroids Affecting Pregnancy Clinical Trial

— PP6  

Official title:

Uterine Fibroids Are a Very Common Finding in Women of Reproductive Age. Ready Safety Study Extracts of Plants Pregnenolone & Pyridoxal Phosphate for Treating Uterine Fibroids in Women of Reproductive Age and Women Pregnancy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04762316
• Other study ID #: Removal the Uterine Fibroids
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: May 2022
• Source: Trieu, Nguyen Thi, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pregnenolone & Pyridoxal Phosphate (PP6) for treating uterine fibroids in women pregnancy to lost the size 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 pregnancy. PP6 against the rapid growth of fibroids under the influence of hormones during pregnancy. Use to PP6 think about regulating stable Oestrogen level and to dissolve fibroids.

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

Description:

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

Clinically has shown that:

• Uterine fibroids are associated with heavy or prolonged menstrual periods, 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 a sufficient Pregnenolone and combined with Coenzyme Pyridoxal Phosphate, 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, 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. Compound presence in the body will curb the development exceed 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 PP6 drug have the disappearance of fibroids, only the image of uterine muscle is thicker than usual.

• 100% of women who received PP6 placebo did not experience any beneficial progress.

• Through study completion, an average of 40 weeks

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids Affecting Pregnancy

Intervention

Drug:
• PP6
Dosage: -Take 1tablet/2 times/day/in throughout pregnancy.

Device:
• PP6 Placebo
Dosage: -Take 1tablet/2 times/day/in throughout pregnancy.

Locations

Country	Name	City	State
Vietnam	Saigon Biopharma Company Limited	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Trieu, Nguyen Thi, M.D.

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use PP6 drugs to lose the size of Uterine Fibroids on Women the Pregnancy.	Measuring the size of uterine fibroid. Monitor the disappearance of benign smooth muscle cell tumors of the uterus	40 weeks

External Links

•   Contemporary Management of Fibroids in Pregnancy
•   Uterine fibroids
•   WO2020095085 - COMPOSITION for TREATING UTERINE FIBROIDS