Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2017-01-26
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
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.
Study Groups
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GINST group
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.
fermented ginseng (GINST)
Intervention group should take fermented ginseng (GINST) capsule 3 times a day, 2 capsules at one time for 12 weeks
Control group
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.
Placebo
Control group should take placebo capsule 3 times a day, 2 capsules at one time for 12 weeks
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Men who have agreed to participate in this trial before the start of the study and who have written an informed consent
Exclusion Criteria
* 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
18 Years
60 Years
MALE
Yes
Sponsors
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Ilwha Co.,Ltd.
UNKNOWN
Jae Hoon Lee
OTHER
Responsible Party
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Jae Hoon Lee
Clinical Fellow
Principal Investigators
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Young Sik Choi, M.D., Ph.D.
Role: STUDY_DIRECTOR
Severance Hospital, Yonsei University
Locations
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Wonju Severance Christian Hospital
Wŏnju, Gangwondo, South Korea
Gil Hospital
Incheon, , South Korea
Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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4-2016-0288
Identifier Type: -
Identifier Source: org_study_id
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