The Therapeutic Effects of Bu Shen Yi Jing Pill on Semen Quality in Sub Fertile Males: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- To determine the change in sperm volume from baseline after treatment with BSYJ pill
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
This is a double-blind study. The randomization master list will be kept with the investigator and both patients and physician will be blinded to the treatment received.
入排标准
- 年龄范围
- 21 Years 至 49 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Placebo
Patients in this arm will be given a placebo pill that resembles the actual Bu Shen Yi Jing Pill.
干预措施: Placebo Drug (Drug)
Bu Shen Yi Jing Pill
Patients in this arm will be given the BSYJ Pill.
干预措施: Bu Shen Yi Jing Pill (Drug)
结局指标
主要结局
To determine the change in sperm volume from baseline after treatment with BSYJ pill
时间窗: 1 year
From sperm samples analyses
To determine the change in sperm morphology from baseline after treatment with BSYJ pill
时间窗: 1 year
From sperm samples analyses
To determine the change in sperm motility from the baseline after treatment with BSYJ pill
时间窗: 1 year
From sperm samples analyses
To determine the change in sperm concentration from the baseline after treatment with BSYJ pill
时间窗: 1 year
From sperm samples analyses
次要结局
- To determine the clinical pregnancy rate and successful delivery rate after BSYJ pill(2 year)
- To study the safety and determine the changes in blood profile after treatment with BSYJ pill(1 year)