Overview

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

Status:
Not yet recruiting
Trial end date:
2024-12-31
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
KK Women's and Children's Hospital
Criteria
Inclusion Criteria:

- Duration of subfertility (both primary and secondary) ≥ 1 year;

- Male patients with any of the three abnormal semen parameters; The definition of
"abnormal semen parameters" is in accordance with the 2010 World Health Organization
criteria, including oligozoospermia (Concentration < 15 x 106), teratozoospermia
(Normal forms < 4%), and asthenozoospermia (Total motility < 40%, or progressive
motility < 32%), or a combination of these three parameters. Semen analysis reports
presented during eligibility screening can come from KK hospital or private clinics,
not dated more than 6 months.

- Based on a prominent TCM diagnosis textbook known as TCM Diagnostics, patients
diagnosed with the TCM syndrome of Kidney Deficiency with Liver Stagnation presents
with the following symptoms:

Main symptoms include:

- Presence of frustration, depression or anger (either one)

- Frequent urination; lower back pain (either one)

- Secondary symptoms include: Frequent sighing; pain in the chest and lower abdominal
quadrant; fatigue; dizziness; tinnitus or memory loss; low libido/ sexual drive; wet
dreams; premature ejaculation; chest tightness; presence of feverish palms and soles;
night sweats; dry mouth; feeling cold or prefer warm; sleep quality; burping or acid
reflux; heel pain

Presence of both main symptoms and 1 secondary symptom allows for the diagnosis of the TCM
syndrome of Kidney Deficiency with Liver Stagnation.

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