AsthenozoospermiaNCT03183999
Effect of Fermented Ginseng (GINST) on Sperm Motility
A study testing fermented ginseng (GINST) in people with Asthenozoospermia, run by Jae Hoon Lee at 3 sites in South Korea.
Trial summary
This randomized, double-blind, placebo-controlled study aimed to evaluate the effect of ginseng(GINST) supplementation for 12 weeks on sperm motility. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Asthenozoospermia
- What is being tested?
- fermented ginseng (GINST)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 26 Jan 2017to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Gil Hospital
Incheon, 21565
Seun joo CHON, M.D., Ph.D., +82-1577-2299, sjchon@gilhospital.com
- Recruiting
Severance Hospital
Seoul, 03722
JAe Hoon LEE, M.D., +82-2-2222230, jhlee126@yuhs.ac
- Recruiting
Wonju Severance Christian Hospital
Wŏnju, Gangwondo, 26426
Yeon Soo Jung, M.D., Ph.D., +82-33-741-0114, ivfys@yonsei.ac.kr
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthenozoospermia
- Being tested
- fermented ginseng (GINST), Placebo
- Medical subject headings
- Asthenozoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboDietary supplement
Control group should take placebo capsule 3 times a day, 2 capsules at one time for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline sperm motility at 12 weeks
Secondary outcomes (3)
Quality of life
Quality of life was evaluated by The Short Form (36) Health Survey(SF-36 questionnaire) at baseline and 12weeks after intervention
Measured: Change from baseline quality of life at 12 weeks
Fatigue questionnaire
Fatigue was evaluated by Fatigue Severity Scale at baseline and 12weeks after intervention
Measured: 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
Measured: Change from baseline Sexual Function Inventory (questionnaire) at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start26 Jan 2017
- Primary completion1 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthenozoospermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled trial for evaluation of sperm motility improvement effect of fermented ginseng
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jae Hoon Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Ilwha Co.,Ltd.
- Responsible party
- Sponsor-investigator, Jae Hoon Lee, Severance Hospital
- Investigators
- Young Sik Choi, M.D., Ph.D., Study director, Severance Hospital, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183999
- Sponsor's protocol ID
- 4-2016-0288
- Status last verified
- Jun 2017
- First submitted
- 17 May 2017
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 10354824Chen 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.
PubMed 11321473Chen 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.
PubMed 7647970
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial for Evaluation of Sperm Motility Improvement Effect of Fermented Ginseng(GINST)
- ClinicalTrials.gov ID
- NCT03183999
- Acronym / sponsor ID
- 4-2016-0288
- Conditions
- Asthenozoospermia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jae Hoon LeeUniversity, hospital or other
- Collaborators
- Ilwha Co.,Ltd.
- Study start
- 26 Jan 2017 (actual)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 12 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled trial for evaluation of sperm motility improvement effect of fermented ginseng
| Arm | Type | Receives |
|---|---|---|
| GINST group | Experimental | Dietary Supplement: fermented ginseng (GINST)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 | Placebo comparator | Dietary Supplement: PlaceboControl 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fermented ginseng (GINST)Intervention group should take fermented ginseng (GINST) capsule 3 times a day, 2 capsules at one time for 12 weeks | Dietary supplement | GINST group |
| PlaceboControl group should take placebo capsule 3 times a day, 2 capsules at one time for 12 weeks | Dietary supplement | Control group |
Primary outcome
Sperm motility
Time frame: Change from baseline sperm motility at 12 weeks
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.
3 secondary outcomes
Quality of life
Time frame: Change from baseline quality of life at 12 weeks
Fatigue questionnaire
Time frame: Change from baseline Fatigue Severity Scale at 12 weeks
Sexual function
Time frame: Change from baseline Sexual Function Inventory (questionnaire) at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Background: PubMed 10354824Chen 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.
- Background: PubMed 11321473Chen 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.
- Background: PubMed 7647970Chen 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.
- Individual participant dataSharing planned: Undecided
Related trials for Asthenozoospermia
Not yet recruitingPhase 2
A Study to Evaluate the Safety and Efficacy of Multiple Dose of STSP-0902 in Patients With Oligozoospermia and/or Asthenozoospermia.
Oligozoospermia and/or Asthenozoospermia
RecruitingObservational study
Efficacy and Safety of a New Sperm Capacitation Method
Reproductive Issues, Male Infertility
RecruitingPhase 2/3
PKB171 Against Placebo in Couples With Mild Male Factor Infertility
Infertility Due to Azoospermia
Recruiting
Effect of Daily Intake of Gazpacho on Semen Quality and Oxidative Stress
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Recruiting
Probiotics on Sperm Quality in Male Infertility Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Sik Choi, M.D., Ph.D. study director
Severance Hospital, Yonsei University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fermented ginseng (GINST) in people with Asthenozoospermia, run by Jae Hoon Lee at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae Hoon LEE, M.D. (+82-10-9985-4676, jhlee126@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm motility (time frame: Change from baseline sperm motility at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03183999, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.