The Therapeutic Effects of Bu Shen Yi Jing Pill on Semen Quality in Sub Fertile Males: a Randomiz… (NCT05290558) | Clinical Trial Compass
Active — Not RecruitingPhase 2
The Therapeutic Effects of Bu Shen Yi Jing Pill on Semen Quality in Sub Fertile Males: a Randomized Controlled Trial
Singapore59 participantsStarted 2022-01-07
Plain-language 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.
Who can participate
Age range21 Years – 49 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 sup…
What they're measuring
1
To determine the change in sperm volume from baseline after treatment with BSYJ pill
Timeframe: 1 year
2
To determine the change in sperm morphology from baseline after treatment with BSYJ pill
Timeframe: 1 year
3
To determine the change in sperm motility from the baseline after treatment with BSYJ pill
Timeframe: 1 year
4
To determine the change in sperm concentration from the baseline after treatment with BSYJ pill