Effect of Fermented Ginseng (GINST) on Sperm Motility

Jae Hoon Lee

Status: Unknown

Conditions: Asthenozoospermia

Treatments: Dietary Supplement: fermented ginseng (GINST); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03183999

4-2016-0288

Details and patient eligibility

About

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

Full 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 <Brief Male Sexual Function Inventory> , <Fatigue Severity Scale>, and <the Short Form (36) Health Survey> measured at baseline and end of the trial.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

GINST group

Experimental group

Description:

Experimental group was 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%. Fermented ginseng (GINST) was supplied.

Treatment:

Dietary Supplement: fermented ginseng (GINST)

Control group

Placebo Comparator group

Description:

Control group was 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%. Placebo was supplied.

Treatment:

Dietary Supplement: Placebo