Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-30 @ 9:40 PM
Study NCT ID:
NCT02285335
Status:
UNKNOWN
Last Update Posted:
2019-03-26
First Post:
2014-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of GINST on Human Semen
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: