Effect of Fermented Ginseng (GINST) on Sperm Motility

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

Detailed Description
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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.

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

Conditions
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Asthenozoospermia

Intervention / Treatment
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* Dietary Supplement: fermented ginseng (GINST)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blind, placebo-controlled trial for evaluation of sperm motility improvement effect of fermented ginseng
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GINST group<br>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. | Dietary Supplement: fermented ginseng (GINST)<br>* Intervention group should take fermented ginseng (GINST) capsule 3 times a day, 2 capsules at one time for 12 weeks<br>|
| Placebo Comparator: Control group<br>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. | Dietary Supplement: Placebo<br>* Control group should take placebo capsule 3 times a day, 2 capsules at one time for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Fatigue questionnaire | Fatigue was evaluated by Fatigue Severity Scale at baseline and 12weeks after intervention | Change from baseline Fatigue Severity Scale at 12 weeks | 
| 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 |