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| Name | Class |
|---|---|
| Ilwha Co.,Ltd. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GINST group | Experimental | 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. |
|
| Control group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fermented ginseng (GINST) | Dietary Supplement | Intervention group should take fermented ginseng (GINST) capsule 3 times a day, 2 capsules at one time for 12 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Because this trial is aimed to evaluate of effect of femented ginseng on sperm motility, participant eligibility is based on biological gender.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jae Hoon LEE, M.D. | Contact | +82-10-9985-4676 | jhlee126@yuhs.ac | |
| Bo Hyon Yun, M.D. | Contact | +82-2-2228-2230 | GARFIELDZZ@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Young Sik Choi, M.D., Ph.D. | Severance Hospital, Yonsei University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonju Severance Christian Hospital | Recruiting | Wŏnju | Gangwondo | 26426 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10354824 | Background | 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. doi: 10.1142/S0192415X9900015X. | |
| 11321473 | Background | 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. doi: 10.1142/S0192415X01000174. |
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| ID | Term |
|---|---|
| D053627 | Asthenozoospermia |
| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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Randomized, double-blind, placebo-controlled trial for evaluation of sperm motility improvement effect of fermented ginseng
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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.
Care provider masking The care providers will be unaware which participant belonged to the experimental group or control group during stuty period.
| Placebo | Dietary Supplement | Control group should take placebo capsule 3 times a day, 2 capsules at one time for 12 weeks |
|
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 |
| Gil Hospital | Recruiting | Incheon | 21565 | South Korea |
|
| Severance Hospital | Recruiting | Seoul | 03722 | South Korea |
|
| 7647970 | Background | Chen X, Lee TJ. Ginsenosides-induced nitric oxide-mediated relaxation of the rabbit corpus cavernosum. Br J Pharmacol. 1995 May;115(1):15-8. doi: 10.1111/j.1476-5381.1995.tb16313.x. |
| D007246 |
| Infertility |
| D052801 | Male Urogenital Diseases |