The Therapeutic Effects of Bu Shen Yi Jing Pill on Semen Quality in Sub Fertile Males: a Randomized Controlled Trial

NCT ID: NCT05290558

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-07
• Study Completion Date: 2024-12-31

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.

Conditions

Male Infertility; Infertility; Traditional Chinese Medication (TCM); Reproductive Issues

Study Design

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

Study Groups

Placebo

Patients in this arm will be given a placebo pill that resembles the actual Bu Shen Yi Jing Pill.

Group Type: PLACEBO_COMPARATOR

Placebo Drug

Intervention Type: DRUG

Placebo contains the ingredients: grounded black rice and permitted colouring. The ingredients are encapsulated within a gelatine capsule.

Dosage of the study drug is as follows: 3 pills each time, for 3 times a day, taken for 6 days every week for 1 year

Bu Shen Yi Jing Pill

Patients in this arm will be given the BSYJ Pill.

Group Type: ACTIVE_COMPARATOR

Bu Shen Yi Jing Pill

Intervention Type: DRUG

Bu Shen Yi Jing Pill contained Radix Pseudostellaria, Fructus Lycii, Radix Et Rhizoma Salviae, Rhizoma Dioscorea, Semen Plantaginis, Semen Cuscuta, Patriniae Herba, Herba Epimedii, Radix Ophiopogonis, Fructus Rubi, Fructus Corni, Bupleurum roots, Fructus Schisandrae Chinensis, Radix Et Rhizoma Glycyrrhizae.

Dosage of the study drug is as follows: 3 pills each time, for 3 times a day, taken for 6 days every week for 1 year

Interventions

Bu Shen Yi Jing Pill

Bu Shen Yi Jing Pill contained Radix Pseudostellaria, Fructus Lycii, Radix Et Rhizoma Salviae, Rhizoma Dioscorea, Semen Plantaginis, Semen Cuscuta, Patriniae Herba, Herba Epimedii, Radix Ophiopogonis, Fructus Rubi, Fructus Corni, Bupleurum roots, Fructus Schisandrae Chinensis, Radix Et Rhizoma Glycyrrhizae.

Dosage of the study drug is as follows: 3 pills each time, for 3 times a day, taken for 6 days every week for 1 year

Intervention Type: DRUG

Placebo Drug

Placebo contains the ingredients: grounded black rice and permitted colouring. The ingredients are encapsulated within a gelatine capsule.

Dosage of the study drug is as follows: 3 pills each time, for 3 times a day, taken for 6 days every week for 1 year

Intervention Type: DRUG

Other Intervention Names

BSYJ Pill; Control drug

Eligibility Criteria

Inclusion Criteria

• Duration of subfertility (both primary and secondary) ≥ 1 year;
• Any or combination of the three abnormal semen parameters, defined according to the 2010 WHO criteria, including

• Oligozoospermia, with sperm concentration less than 15 x 10^6,
• Teratozoospermia, with normal sperm morphology less than 4%, and
• Asthenozoospermia, with total sperm motility less than 40%, or progressive sperm motility less than 32%.
• Diagnosed with TCM syndrome of Kidney Deficiency Based on a prominent TCM diagnosis textbook known as TCM Diagnostics, the main symptoms patients need to fulfil for Kidney Deficiency are either nocturnal polyuria or lower back pain. In addition, patients need to fulfil any 1 of the secondary symptoms, including fatigue; dizziness; tinnitus or deafness; memory loss; excessive urination; low libido; wet dreams; premature ejaculation; presence of feverish palms and soles or night sweats; dry mouth or throat; cold intolerance or preference for warmth; poor sleep quality. Presence of both 1 main symptom and 1 secondary symptom allows for the diagnosis of the Kidney Deficiency syndrome.

Patients who meet all three criteria mentioned above will be included in the study.

Exclusion Criteria

• Azoospermia and severe oligoasthenoteratozoospermia;
• Aspermia;
• Varicocele;
• Recent urogenital infections;
• Y chromosome deletions;
• Abnormal karyotypes
• History of chemotherapy and / or radiotherapy;
• Patients on fertility supplements or supplements marketed to improve fertility;
• Patients with uncontrolled diabetes or/and hypertension; with uncontrolled chronic medical conditions
• Patients currently already on BSYJ pills treatment

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tat Xin Ee, MD

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

Locations

KK Women's and Children's Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

2020/2019

Identifier Type: -

Identifier Source: org_study_id