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

NCT05290558 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 2020/2019
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Male Infertility; Infertility; Traditional Chinese Medication (TCM); Reproductive Issues

Keywords

Infertility; Sperm; Traditional Medicine

Outcome Measures

Primary Outcomes (4)

• To determine the change in sperm volume from baseline after treatment with BSYJ pill

  From sperm samples analyses

  1 year

• To determine the change in sperm morphology from baseline after treatment with BSYJ pill

  From sperm samples analyses

  1 year

• To determine the change in sperm motility from the baseline after treatment with BSYJ pill

  From sperm samples analyses

  1 year

• To determine the change in sperm concentration from the baseline after treatment with BSYJ pill

  From sperm samples analyses

  1 year

Secondary Outcomes (2)

• 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

Other Outcomes (25)

• To assess the common side effects of the BSYJ pill

  1 year

• To assess the common gastrointestinal side effects of the BSYJ pill

  1 year

• To evaluate safety profile of BSYJ pill

  Up to 1 year after recruitment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients in this arm will be given a placebo pill that resembles the actual Bu Shen Yi Jing Pill.

Drug: Placebo Drug

Bu Shen Yi Jing Pill

ACTIVE COMPARATOR

Patients in this arm will be given the BSYJ Pill.

Drug: Bu Shen Yi Jing Pill

Interventions

Bu Shen Yi Jing Pill DRUG

Bu Shen Yi Jing Pill contained Radix Pseudostellaria, Fructus Lycii, Radix Et Rhizoma Salviae, Rhizoma Dioscorea, Semen Plantaginis, Semen Cuscuta, Patriniae Herba, Herba Epimedii, Radix Ophiopogonis, Fructus Rubi, Fructus Corni, Bupleurum roots, Fructus Schisandrae Chinensis, Radix Et Rhizoma Glycyrrhizae. Dosage of the study drug is as follows: 3 pills each time, for 3 times a day, taken for 6 days every week for 1 year

Also known as: BSYJ Pill

Bu Shen Yi Jing Pill

Placebo Drug DRUG

Placebo contains the ingredients: grounded black rice and permitted colouring. The ingredients are encapsulated within a gelatine capsule. Dosage of the study drug is as follows: 3 pills each time, for 3 times a day, taken for 6 days every week for 1 year

Also known as: Control drug

Placebo

Eligibility Criteria

• Age: 21 Years - 49 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

MeSH Terms

Conditions

Infertility, Male; Infertility

Interventions

Drug and Narcotic Control

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Legislation, Drug; Legislation as Topic; Social Control, Formal; Health Care Economics and Organizations; Pharmacy Administration; Organization and Administration; Health Services Administration

Study Officials

• Tat Xin Ee, MD

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a double-blinded randomised control trial. Participants will be randomised using block randomization by a pre-determined randomisation schedule generated by a biostatistician in block size of 4. Enrolment and assignment of intervention will be carried out by an investigator. The investigators will perform block randomization of the subjects in blocks of 4 in the ratio of 1:1 such that 2 will be assigned to treatment and 2 will be assigned to placebo.

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: March 22, 2022
• Study Start: January 7, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)