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Efficacy and Safety of DA-9401 on Improvement of Sperm Motility

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03258437
Enrollment
27
Registered
2017-08-23
Start date
2016-04-12
Completion date
2018-01-30
Last updated
2018-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spermatocele

Keywords

sperm motility, Clinical Trial , DA-9401

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTDA-9401
DIETARY_SUPPLEMENTPlacebo

Placebo for 12 weeks.

Sponsors

Korean Society for Sexual Medicine and Andrology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 20-55 years * sperm motility 40\ 69%

Exclusion criteria

* History of alcohol or substance abuse * Participation in any other clinical trials within past 1 months * intense constipation

Design outcomes

Primary

MeasureTime frameDescription
Changes of Sperm motility12 weeksChanges of sperm profile were assessed before and after the intervention

Secondary

MeasureTime frameDescription
Changes of Sperm count12 weeksChanges of Sperm count(X10\^6(M)/ml) profile were assessed before and after the intervention
Changes of Ejaculated volume12 weeksChanges of Ejaculated volume(ml) profile were assessed before and after the intervention
Changes of Sperm morphology12 weeksChanges of Sperm morphology(%) profile were assessed before and after the intervention
Changes of Ejaculated pH12 weeksChanges of Ejaculated pH profile were assessed before and after the intervention
Changes of IIEF(International Index of Erectile Function)12 weeksChanges of questionnaire profile were assessed before and after the intervention
Changes of MFS(Multidimensional Fatigue Scale)12 weeksChanges of questionnaire profile were assessed before and after the intervention
Changes of hormone(Total testosterone, FSH, LH)12 weeksChanges of hormone{Total testosterone(ng/ml), FSH and LH(mlU/ml)} profile were assessed before and after the intervention

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026