Effect of Fermented Ginseng (GINST) on Sperm Motility

NCT03183999 | Unknown DMC

• 1 other identifier: 4-2016-0288
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Asthenozoospermia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quality of life

  Change from baseline quality of life at 12 weeks

• Fatigue questionnaire

  Change from baseline Fatigue Severity Scale at 12 weeks

• Sexual function

  Change from baseline Sexual Function Inventory (questionnaire) at 12 weeks

Study Arms (2)

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.

Dietary Supplement: fermented ginseng (GINST)

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.

Dietary Supplement: Placebo

Interventions

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

GINST group

Placebo DIETARY_SUPPLEMENT

Control group should take placebo capsule 3 times a day, 2 capsules at one time for 12 weeks

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Because this trial is aimed to evaluate of effect of femented ginseng on sperm motility, participant eligibility is based on biological gender.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jae Hoon Lee: lead
• Ilwha Co.,Ltd.: collaborator

Study Sites (3)

Wonju Severance Christian Hospital

Wŏnju, Gangwondo, 26426, South Korea

RECRUITING

Gil Hospital

Incheon, 21565, South Korea

RECRUITING

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Related Publications (3)

• 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.

  PMID: 10354824 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.

  PMID: 11321473 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.

  PMID: 7647970 BACKGROUND

MeSH Terms

Conditions

Asthenozoospermia

Condition Hierarchy (Ancestors)

Infertility, Male; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Young Sik Choi, M.D., Ph.D.

  Severance Hospital, Yonsei University

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Fellow

Model Details: Randomized, double-blind, placebo-controlled trial for evaluation of sperm motility improvement effect of fermented ginseng

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: June 12, 2017
• Study Start: January 26, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 31, 2017
• Last Updated: June 12, 2017

Record last verified: 2017-06

Locations

KR (3)