Clinical trial NCT03183999: Effect of Fermented Ginseng (GINST) on Sperm Motility
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial for Evaluation of Sperm Motility Improvement Effect of Fermented Ginseng(GINST)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthenozoospermia
Lead sponsor: Severance Hospital
Sponsor class: OTHER
Collaborators: name: Ilwha Co.,Ltd.
First posted: 2017-06-12
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled trial for evaluation of sperm motility improvement effect of fermented ginseng
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sperm motility
timeFrame: Change from baseline sperm motility at 12 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: Change from baseline quality of life at 12 weeks
measure: Fatigue questionnaire
timeFrame: Change from baseline Fatigue Severity Scale at 12 weeks
measure: Sexual function
timeFrame: Change from baseline Sexual Function Inventory (questionnaire) at 12 weeks
Other outcomes:
Locations:
city: Wŏnju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwondo
city: Incheon
country: Korea, Republic of
facility: Gil Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital, Yonsei University
name: Young Sik Choi, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.