Asthenozoospermia Clinical Trial
Official title:
Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial for Evaluation of Sperm Motility Improvement Effect of Fermented Ginseng(GINST)
This randomized, double-blind, placebo-controlled study aimed to evaluate the effect of ginseng(GINST) supplementation for 12 weeks on sperm motility.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2017 |
Est. primary completion date | December 1, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Male between 18 and 60 years old - Men who have agreed to participate in this trial before the start of the study and who have written an informed consent Exclusion Criteria: - Those who are diagnosed and treated for hypertension (systolic blood pressure> 140mmHg and diastolic blood pressure> 90mmHg) - Patients with a history of chemotherapy for malignant tumors - Patients with a history of taking testosterone or antiandrogens within 1 month - BMI> 30 or BMI <18 - Those who have the following results in the blood test: AST(aspartate aminotransferase ), ALT(Alanine transaminase) > 2 times the upper limit of reference range; Serum Creatinine> 2.0 mg / dl - Those who ingested drugs (eg, folic acid, L-carn, HCG(human chorionic gonadotropin ), FSH(Follicle-stimulating hormone), Clomiphene, etc.) that have an effect on sperm motility within 2 weeks before the screening day. - Persons who have received antipsychotic medication within 2 months before the screening test - Those who have history of alcoholism or substance abuse |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Gil Hospital | Incheon | |
Korea, Republic of | Severance Hospital | Seoul | |
Korea, Republic of | Wonju Severance Christian Hospital | Wonju | Gangwondo |
Lead Sponsor | Collaborator |
---|---|
Jae Hoon Lee | Ilwha Co.,Ltd. |
Korea, Republic of,
Chen JC, Chen LD, Tsauer W, Tsai CC, Chen BC, Chen YJ. Effects of Ginsenoside Rb2 and Rc on inferior human sperm motility in vitro. Am J Chin Med. 2001;29(1):155-60. — View Citation
Chen JC, Xu MX, Chen LD, Chen YN, Chiu TH. Effect of panax notoginseng extracts on inferior sperm motility in vitro. Am J Chin Med. 1999;27(1):123-8. — View Citation
Chen X, Lee TJ. Ginsenosides-induced nitric oxide-mediated relaxation of the rabbit corpus cavernosum. Br J Pharmacol. 1995 May;115(1):15-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sperm motility | Sperm motility is evaluated by Computer-Aided Semen Analysis, or CASA. Sperm motility will be expressed as '% motile' , the percent of cells that are motile. According to WHO definition, asthenozoospermia is regarded as falling below 40% motility in this study. | Change from baseline sperm motility at 12 weeks | |
Secondary | Quality of life | Quality of life was evaluated by The Short Form (36) Health Survey(SF-36 questionnaire) at baseline and 12weeks after intervention | Change from baseline quality of life at 12 weeks | |
Secondary | Fatigue questionnaire | Fatigue was evaluated by Fatigue Severity Scale at baseline and 12weeks after intervention | Change from baseline Fatigue Severity Scale at 12 weeks | |
Secondary | Sexual function | Sexual function was evaluated by Brief Male Sexual Function Inventory (questionnaire) at baseline and 12weeks after intervention | Change from baseline Sexual Function Inventory (questionnaire) at 12 weeks |
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