Composition for Treating Spermatogenesis and Semen Disorders / FPT-20

NCT ID: NCT05399212

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-29
• Study Completion Date: 2022-05-20

Brief Summary

Research to develop a new, natural-derived formulation that eliminates inflammatory tissue and regenerates new tissue of the lobules, epithelium of the tubules, and connective tissue surrounding the seminiferous tubules in the testes. It restores Leydig cells and Sertoli cells' function (because the inflamed testicles were unable to perform spermatogenesis).

Detailed Description

FPT-20 has stabilized cortisol levels, maintained stable B-lymphocytes in the body, verified by quantitative tests of blood B-lymphocytes and blood cortisol, cut off the chronic inflammation chain, promoted the regeneration of the epithelium of the coiled ducts, and repairs the connective tissue surrounding the coils.

Select a type of flavonoid that has the ability to protect human body cells by destroying toxic proteins. Targeted flavonoids are selected for multiple simultaneous effects, acting as a chemotactic or physiological modifier. Many studies have shown that flavonoids can also act as cell cycle inhibitors, which can also cause cancer cell death at an early stage (at the stage of a few cells). There have been many documents demonstrating that some flavonoids have the ability to kill cancer cells, stabilize stages of cell differentiation, and improve immunity. Flavonoids present in FPT-20 protect and regenerate cells, clean up inflammatory and fibrotic cells, and facilitate the growth of germ cells.

The selected flavonoids in the preparation are also used to regenerate the epithelium in the lumen of the seminiferous tubules, ensure the perfusion of the lobules, and stabilize the spermatogenesis process.

FPT-20 is easily distributed in high concentrations in immune cells. It has natural antibacterial activity, promotes lymphocyte proliferation, and is rapidly consumed during inflammation. The effects show a prominent role in the regulation of the immune system, and there is a high degree of interaction, which requires more research to understand its mechanism, FPT-20 will not be effective in the absence of one of the components selected to participate in the test.

FPT-20 will reach its therapeutic effect after 6-12 months. After 6-12 months, an amount of progressively motile sperm was found in the semen.

According to research, FPT-20 created a homeostasis, protecting cell membranes, cutting off the cell's inflammatory chain, and preventing transcription and translation errors. The mediators regulated the protective responses in the body. Cytokines that have a beneficial effect through specific receptors, and many other unexplained processes, have altered the spermatogenesis status of the testes. The body will absorb the components in FPT-20 through the small intestine wall, this metabolism has created a significant amount of B lymphocytes to provide for the process of restoring the function of the testicles. An appropriately calculated dose of FPT-20 is provided during the treatment, using precursors, enzymes, and flavonoids available in nature to supplement and interfere with biochemical processes taking place in the body. The extracts in the preparation should be used regularly (>6 months) until the therapeutic purpose is achieved. The product has offered hope to patients who are unable to produce sperm from spermatogonia (because the process has been disrupted). Stabilize the semen pH within good limits, to produce high-quality sperm as well as to achieve efficiency into egg penetration.

Conditions

Spermatogenesis and Semen Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

FPT-20

FPT-20 should be used regularly (\>6 to 12 months) until the therapeutic purpose is achieved.

Group Type: EXPERIMENTAL

FPT-20

Intervention Type: DRUG

FPT-20 should be used regularly, the daily maintenance dose is 1 tablet once a day(\>6 to 12 months) until the therapeutic purpose is achieved.

Interventions

FPT-20

FPT-20 should be used regularly, the daily maintenance dose is 1 tablet once a day(\>6 to 12 months) until the therapeutic purpose is achieved.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The selected person has evidence of spermatogenesis disorder, no sperm, and weak sperm that do not meet the standards in terms of quantity and quality.
• There are signs of orchitis.
• Accepting patients with other comorbidities such as metabolic diseases, congenital or acquired immunodeficiency, HIV/AIDS, HBV, HCV, and Tuberculosis.

Exclusion Criteria

• Do not select patients with advanced cancer.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

TRAN MINH DUC, MD

UNKNOWN

Sponsor Role: collaborator

Trieu, Nguyen Thi, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nguyen Thi Trieu, Dr.

Role: STUDY_CHAIR

Trieu, Nguyen Thi, M.D.

Locations

Saigon Biopharma LLC

Wilmington, Delaware, United States

Saigon Biopharma Company Limited

Hồ Chí Minh, Ho Chi Minh City, Vietnam

Countries

United States; Vietnam

Other Identifiers

Therapy to spermatogenesis

Identifier Type: -

Identifier Source: org_study_id