Effect of Fermented Ginseng (GINST) on Sperm Motility

Asthenozoospermia Clinical Trial

Official title:

Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial for Evaluation of Sperm Motility Improvement Effect of Fermented Ginseng(GINST)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03183999
• Other study ID #: 4-2016-0288
• Status: Recruiting
• Phase: N/A
• First received: May 17, 2017
• Last updated: June 9, 2017
• Start date: January 26, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: June 2017
• Source: Severance Hospital
• Contact: Jae Hoon LEE, M.D.
• Phone: +82-10-9985-4676
• Email: jhlee126[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized, double-blind, placebo-controlled study aimed to evaluate the effect of ginseng(GINST) supplementation for 12 weeks on sperm motility.

Description:

This multicenter, randomized, double-blind, placebo-controlled clinical trial was aimed to evaluate of sperm motility improvement effect of fermented ginseng(GINST). Experimental arm and control arm were randomly assigned among the volunteers who met the inclusion criteria: men between the ages of 18 and 60 who had sperm motility of less than 32%.

To experimental arm, capsules including 160mg of fermented ginseng(GINST) ingredients will be provided for 12 weeks. To control arm, capsules of the same shape and weight as GINST capsules will be provided. These capsules are made of a cellulose component.

Primary outcome is sperm motility. Secondary outcome are , , and measured at baseline and end of the trial.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Asthenozoospermia

Intervention

Dietary Supplement:
• fermented ginseng (GINST)
Intervention group should take fermented ginseng (GINST) capsule 3 times a day, 2 capsules at one time for 12 weeks
• Placebo
Control group should take placebo capsule 3 times a day, 2 capsules at one time for 12 weeks

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Jae Hoon Lee	Ilwha Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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

Outcome

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