Effect of Fermented Ginseng (GINST) on Sperm Motility
Primary Purpose
Asthenozoospermia
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
fermented ginseng (GINST)
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Asthenozoospermia
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
Sites / Locations
- Wonju Severance Christian HospitalRecruiting
- Gil HospitalRecruiting
- Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GINST group
Control group
Arm Description
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 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Quality of life
Quality of life was evaluated by The Short Form (36) Health Survey(SF-36 questionnaire) at baseline and 12weeks after intervention
Fatigue questionnaire
Fatigue was evaluated by Fatigue Severity Scale at baseline and 12weeks after intervention
Sexual function
Sexual function was evaluated by Brief Male Sexual Function Inventory (questionnaire) at baseline and 12weeks after intervention
Full Information
NCT ID
NCT03183999
First Posted
May 17, 2017
Last Updated
June 9, 2017
Sponsor
Jae Hoon Lee
Collaborators
Ilwha Co.,Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03183999
Brief Title
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
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 26, 2017 (Actual)
Primary Completion Date
December 1, 2017 (Anticipated)
Study Completion Date
December 31, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jae Hoon Lee
Collaborators
Ilwha Co.,Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthenozoospermia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled trial for evaluation of sperm motility improvement effect of fermented ginseng
Masking
ParticipantCare Provider
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GINST group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
fermented ginseng (GINST)
Intervention Description
Intervention group should take fermented ginseng (GINST) capsule 3 times a day, 2 capsules at one time for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Control group should take placebo capsule 3 times a day, 2 capsules at one time for 12 weeks
Primary Outcome Measure Information:
Title
Sperm motility
Description
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.
Time Frame
Change from baseline sperm motility at 12 weeks
Secondary Outcome Measure Information:
Title
Quality of life
Description
Quality of life was evaluated by The Short Form (36) Health Survey(SF-36 questionnaire) at baseline and 12weeks after intervention
Time Frame
Change from baseline quality of life at 12 weeks
Title
Fatigue questionnaire
Description
Fatigue was evaluated by Fatigue Severity Scale at baseline and 12weeks after intervention
Time Frame
Change from baseline Fatigue Severity Scale at 12 weeks
Title
Sexual function
Description
Sexual function was evaluated by Brief Male Sexual Function Inventory (questionnaire) at baseline and 12weeks after intervention
Time Frame
Change from baseline Sexual Function Inventory (questionnaire) at 12 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Because this trial is aimed to evaluate of effect of femented ginseng on sperm motility, participant eligibility is based on biological gender.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Hoon LEE, M.D.
Phone
+82-10-9985-4676
Email
jhlee126@yuhs.ac
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Hyon Yun, M.D.
Phone
+82-2-2228-2230
Email
GARFIELDZZ@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Sik Choi, M.D., Ph.D.
Organizational Affiliation
Severance Hospital, Yonsei University
Official's Role
Study Director
Facility Information:
Facility Name
Wonju Severance Christian Hospital
City
Wŏnju
State/Province
Gangwondo
ZIP/Postal Code
26426
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yeon Soo Jung, M.D., Ph.D.
Phone
+82-33-741-0114
Email
ivfys@yonsei.ac.kr
Facility Name
Gil Hospital
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seun joo CHON, M.D., Ph.D.
Phone
+82-1577-2299
Email
sjchon@gilhospital.com
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JAe Hoon LEE, M.D.
Phone
+82-2-2222230
Email
jhlee126@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
10354824
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.
Results Reference
background
PubMed Identifier
11321473
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.
Results Reference
background
PubMed Identifier
7647970
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.
Results Reference
background
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Effect of Fermented Ginseng (GINST) on Sperm Motility
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