The purpose of the study is to evaluate the effect of GINST on human semen. The study is a pilot study, designed as open-label, prospective randomized clinical trial using GINST either 500mg/capsule (panax ginseng 0.96g/day) or 1000mg/capsule (panax ginseng 1.92g/day), two capsules at once, three times a day for 12 weeks. GINST(Ilhwa, Republic of Korea) is a dietary supplement capsule, which is made with 6 year-old Korean red ginseng (Panax ginseng). Expected participants are to be male partners of female patients who visit infertility clinic at Severance hospital, whose total motile sperm count is more than 0.5x106 by semen analysis using computer aided sperm analyzer (CASA). Semen analysis, blood test, questionaires are planned to be performed 2 times, on the initial visit and after 12weeks of GINST treatment. Semen analysis will reveal ejaculated volume, sperm count, motility, morphology, total leukocyte count, total motile sperm count, further analysis including sperm chromatin assessment to examine the quality of sperm and malondialdehyde (MDA) analysis of seminal fluid to assess oxidative stress will be performed. Blood test will be done including serum follicle stimulating hormone (FSH), luteinizing hormone (LH), total and free testosterone. Quality of life, sexual performance before and after taking GINST will be evaluated using questionaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
The study is designed with using GINST either 500mg/capsule or 1000mg/capsule, two capsules at once, three times a day for 12 weeks.
Severance hospital
Seoul, South Korea
RECRUITINGSemen quality (assessed by computer aided semen analysis and sperm chromatin assay, malondialdehyde (MDA) analysis)
Semen quality assessed by computer aided semen analysis and sperm chromatin assay, malondialdehyde (MDA) analysis
Time frame: 12 week
serum hormones (serum FSH(follicle stimulating hormone), LH(luteinizing hormone), testosterone)
serum FSH(follicle stimulating hormone), LH(luteinizing hormone), testosterone
Time frame: 12 week
Quality of Life (SF-36, Brief sexual function inventory, fatigue severity scale)
Assessment of quality of life by questionaire (SF-36, Brief sexual function inventory, fatigue severity scale)
Time frame: 12 week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.