Effect of Fermented Ginseng (GINST) on Sperm Motility

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

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

Study Overview

• Status: Unknown
• Conditions: Asthenozoospermia
• Intervention / Treatment: Dietary supplement: fermented ginseng (GINST); Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bo Hyon Yun, M.D.; Phone Number: +82-2-2228-2230; Email: GARFIELDZZ@yuhs.ac

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of, 21565
    • Recruiting
    • Gil Hospital
    • Contact: Seun joo CHON, M.D., Ph.D.; Phone Number: +82-1577-2299; Email: sjchon@gilhospital.com
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Severance Hospital
    • Contact: JAe Hoon LEE, M.D.; Phone Number: +82-2-2222230; Email: jhlee126@yuhs.ac
  • Gangwondo
    • Wŏnju, Gangwondo, Korea, Republic of, 26426
      • Recruiting
      • Wonju Severance Christian Hospital
      • Contact: Yeon Soo Jung, M.D., Ph.D.; Phone Number: +82-33-741-0114; Email: ivfys@yonsei.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jae Hoon Lee
• Collaborators: Ilwha Co.,Ltd.
• Investigators: Study Director: Young Sik Choi, M.D., Ph.D., Severance Hospital, Yonsei University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 31, 2017

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: June 9, 2017
• First Posted (Actual): June 12, 2017

Study Record Updates

• Last Update Posted (Actual): June 12, 2017
• Last Update Submitted That Met QC Criteria: June 9, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility, Male; Infertility; Asthenozoospermia
• Other Study ID Numbers: 4-2016-0288

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No