SpermatoceleNCT03258437
Efficacy and Safety of DA-9401 on Improvement of Sperm Motility
A study testing DA-9401 in people with Spermatocele, run by Korean Society for Sexual Medicine and Andrology at 1 site in South Korea.
Trial summary
This study was conducted to investigate the effects of daily supplementation of Allium cepa L. and Cuscuta chinensis Lam. Extract Mixtures (DA-9401) on improvement of sperm motility. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Spermatocele
- What is being tested?
- DA-9401
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Apr 2016to 30 Jan 2018
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-55 years
- sperm motility 40~69%
Who cannot join
- History of alcohol or substance abuse
- Participation in any other clinical trials within past 1 months
- intense constipation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonbuk National University Hospital of urology
Jeonju, Jeollabuk-do, 560-822
About this study
Official title: A 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Allium Cepa L. and Cuscuta Chinensis Lam. Extract Mixtures (DA-9401) on Improvement of Sperm Motility
This study was conducted to investigate the effects of daily supplementation of Allium cepa L. and Cuscuta chinensis Lam. Extract Mixtures (DA-9401) on improvement of sperm motility.
Read the detailed description
This study was a 12 weeks, multi-center, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Allium cepa L. and Cuscuta chinensis Lam. Extract Mixtures (DA-9401) or a placebo group. sperm motility profiles before and after the intervention.
- Conditions
- Spermatocele
- Being tested
- DA-9401, Placebo
- Keywords
- sperm motility, Clinical Trial , DA-9401
- Medical subject headings
- Spermatocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-9401Dietary supplement
Also called capsules (4cap/d, 2.16 g/d) for 12 weeks.
PlaceboDietary supplement
Placebo for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| DA-9401 | Experimental | capsules (4cap/d, 2.16 g/d) for 12 weeks. Receives: Dietary Supplement: DA-9401 |
| Placebo | Placebo comparator | Placebo for 12 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Sperm motility
Changes of sperm profile were assessed before and after the intervention
Measured: 12 weeks
Secondary outcomes (7)
Changes of Sperm count
Changes of Sperm count(X10^6(M)/ml) profile were assessed before and after the intervention
Measured: 12 weeks
Changes of Ejaculated volume
Changes of Ejaculated volume(ml) profile were assessed before and after the intervention
Measured: 12 weeks
Changes of Sperm morphology
Changes of Sperm morphology(%) profile were assessed before and after the intervention
Measured: 12 weeks
Changes of Ejaculated pH
Changes of Ejaculated pH profile were assessed before and after the intervention
Measured: 12 weeks
Changes of hormone(Total testosterone, FSH, LH)
Changes of hormone{Total testosterone(ng/ml), FSH and LH(mlU/ml)} profile were assessed before and after the intervention
Measured: 12 weeks
Changes of IIEF(International Index of Erectile Function)
Changes of questionnaire profile were assessed before and after the intervention
Measured: 12 weeks
Changes of MFS(Multidimensional Fatigue Scale)
Changes of questionnaire profile were assessed before and after the intervention
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start12 Apr 2016
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpermatoceleStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korean Society for Sexual Medicine and Andrology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Park Jong Kwan, Korean Society for Sexual Medicine and Andrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258437
- Sponsor's protocol ID
- DA-9401-SM
- Status last verified
- Mar 2018
- First submitted
- 5 Jul 2017
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Allium Cepa L. and Cuscuta Chinensis Lam. Extract Mixtures (DA-9401) on Improvement of Sperm Motility
- ClinicalTrials.gov ID
- NCT03258437
- Acronym / sponsor ID
- DA-9401-SM
- Conditions
- Spermatocele
- Keywords
- sperm motility, Clinical Trial , DA-9401
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Korean Society for Sexual Medicine and AndrologyUniversity, hospital or other
- Study start
- 12 Apr 2016 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 23 Aug 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 study was conducted to investigate the effects of daily supplementation of Allium cepa L. and Cuscuta chinensis Lam. Extract Mixtures (DA-9401) on improvement of sperm motility.
Detailed description
This study was a 12 weeks, multi-center, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Allium cepa L. and Cuscuta chinensis Lam. Extract Mixtures (DA-9401) or a placebo group. sperm motility profiles before and after the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-9401 | Experimental | Dietary Supplement: DA-9401capsules (4cap/d, 2.16 g/d) for 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo for 12 weeks. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 20-55 years
- sperm motility 40~69%
Key exclusion criteria (3 listed)
- History of alcohol or substance abuse
- Participation in any other clinical trials within past 1 months
- intense constipation
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 |
|---|---|---|
| DA-9401Also: capsules (4cap/d, 2.16 g/d) for 12 weeks. | Dietary supplement | DA-9401 |
| PlaceboPlacebo for 12 weeks. | Dietary supplement | Placebo |
Primary outcome
Changes of Sperm motility
Time frame: 12 weeks
Changes of sperm profile were assessed before and after the intervention
7 secondary outcomes
Changes of Sperm count
Time frame: 12 weeks
Changes of Ejaculated volume
Time frame: 12 weeks
Changes of Sperm morphology
Time frame: 12 weeks
Changes of Ejaculated pH
Time frame: 12 weeks
Changes of hormone(Total testosterone, FSH, LH)
Time frame: 12 weeks
Changes of IIEF(International Index of Erectile Function)
Time frame: 12 weeks
Changes of MFS(Multidimensional Fatigue Scale)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DA-9401 in people with Spermatocele, run by Korean Society for Sexual Medicine and Andrology at 1 site 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 3 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: finished, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Sperm motility (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2018.