Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT05290558
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
49 Years
Study:
NCT05290558
Study Brief:
Protocol Section:
NCT05290558