Status:
ACTIVE_NOT_RECRUITING
The Therapeutic Effects of Bu Shen Yi Jing Pill on Semen Quality in Sub Fertile Males: a Randomized Controlled Trial
Lead Sponsor:
KK Women's and Children's Hospital
Conditions:
Male Infertility
Infertility
Eligibility:
MALE
21-49 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT05290558
Start Date
January 7 2022
End Date
December 31 2024
Last Update
October 10 2024
Active Locations (1)
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1
KK Women's and Children's Hospital
Singapore, Singapore, 229899