Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
Study NCT ID:
NCT05290558
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-10
First Post:
2021-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Therapeutic Effects of Bu Shen Yi Jing Pill on Semen Quality in Sub Fertile Males: a Randomized Controlled Trial
Sponsor:
KK Women's and Children's Hospital
Organization:
Study Overview
Official Title:
The Therapeutic Effects of Bu Shen Yi Jing Pill on Semen Quality in Sub Fertile Males: a Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the safety and efficacy of Bu Shen Yi Jing (BSYJ) Pill , a type of traditional Chinese medicine, in improving male subfertility and semen parameters.
Detailed Description:
Subfertility is defined as a failure to conceive after 1 year of regular unprotected intercourse. Impaired fertility affects 10 to 15% of couples and male factor is the cause of subfertility in 25 to 40% of couples. With increasing paternal age, semen volume, sperm motility and the percentage of sperm with normal morphology decreases. The majority of men who present with subfertility have either abnormal sperm density, motility or morphology, or a combination of the above, and treatment for this condition is varied and empirical.
There is a paucity of studies and randomized controlled trials to guide treatment of male factor subfertility. Various antioxidant formulations and multivitamins have been used empirically but have not been shown consistently to improve sperm counts and viability. When treatment fails, assisted reproduction will be the last resort. All assisted reproduction treatments are associated with medical, financial and emotional burden. Given the lack of proven treatment options in Western Medicine, Traditional Chinese Medicine (TCM) may provide a viable complementary treatment option. One such option is the Bu Shen Yi Jing (BSYJ) pill.
A clinical observational study conducted by the team in Singapore Thong Chai Medical on subfertile male patients with poor sperm quality and a body constitution of Kidney Deficiency showed that 2 courses of BSYJ pill over a 6 months' duration resulted in successful conception of 33% of azoospermic male patients (n = 60). In a subgroup of patients where serial sperm analysis was available (n=10), the percentage of sperm with grade A motility increased from a median of 22.6 ± 2.4% pre-treatment to 35.1 ± 3.2% post treatment (p \< 0.05); and the hyaluronic binding assay improved from 33.2 ± 2.4% to 72 ± 4.6% (p \< 0.05). This suggests that BSYJ pills possibly works on improving the motility of the sperms in patients having the Kidney deficiency body constitution.
As such, this study aims to validate these hypotheses and anecdotal evidence by conducting a safety and efficacy study of the BSYJ pill on a prospective cohort.
There is a paucity of studies and randomized controlled trials to guide treatment of male factor subfertility. Various antioxidant formulations and multivitamins have been used empirically but have not been shown consistently to improve sperm counts and viability. When treatment fails, assisted reproduction will be the last resort. All assisted reproduction treatments are associated with medical, financial and emotional burden. Given the lack of proven treatment options in Western Medicine, Traditional Chinese Medicine (TCM) may provide a viable complementary treatment option. One such option is the Bu Shen Yi Jing (BSYJ) pill.
A clinical observational study conducted by the team in Singapore Thong Chai Medical on subfertile male patients with poor sperm quality and a body constitution of Kidney Deficiency showed that 2 courses of BSYJ pill over a 6 months' duration resulted in successful conception of 33% of azoospermic male patients (n = 60). In a subgroup of patients where serial sperm analysis was available (n=10), the percentage of sperm with grade A motility increased from a median of 22.6 ± 2.4% pre-treatment to 35.1 ± 3.2% post treatment (p \< 0.05); and the hyaluronic binding assay improved from 33.2 ± 2.4% to 72 ± 4.6% (p \< 0.05). This suggests that BSYJ pills possibly works on improving the motility of the sperms in patients having the Kidney deficiency body constitution.
As such, this study aims to validate these hypotheses and anecdotal evidence by conducting a safety and efficacy study of the BSYJ pill on a prospective cohort.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: