Asthenozoospermia
Conditions
Brief summary
This randomized, double-blind, placebo-controlled study aimed to evaluate the effect of ginseng(GINST) supplementation for 12 weeks on sperm motility.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTfermented ginseng (GINST)
Intervention group should take fermented ginseng (GINST) capsule 3 times a day, 2 capsules at one time for 12 weeks
DIETARY_SUPPLEMENTPlacebo
Control group should take placebo capsule 3 times a day, 2 capsules at one time for 12 weeks
Sponsors
Ilwha Co.,Ltd.
Jae Hoon Lee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
1. Participant masking: To intervention arm, capsules including 160mg of fermented ginseng(GINST) ingredients will be provided. To control arm, capsules of the same shape and weight as GINST capsules will be provided. These apsules are made of a cellulose component. 2. Care provider masking The care providers will be unaware which participant belonged to the experimental group or control group during stuty period.
Intervention model description
Randomized, double-blind, placebo-controlled trial for evaluation of sperm motility improvement effect of fermented ginseng
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sperm motility | Change from baseline sperm motility at 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | Change from baseline quality of life at 12 weeks | Quality of life was evaluated by The Short Form (36) Health Survey(SF-36 questionnaire) at baseline and 12weeks after intervention |
| Fatigue questionnaire | Change from baseline Fatigue Severity Scale at 12 weeks | Fatigue was evaluated by Fatigue Severity Scale at baseline and 12weeks after intervention |
| Sexual function | Change from baseline Sexual Function Inventory (questionnaire) at 12 weeks | Sexual function was evaluated by Brief Male Sexual Function Inventory (questionnaire) at baseline and 12weeks after intervention |
Countries
South Korea
Contacts
Primary ContactJae Hoon LEE, M.D.
Backup ContactBo Hyon Yun, M.D.
Outcome results
None listed