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

Not Applicable
Completed
Conditions
Spermatocele
Interventions
Dietary Supplement: DA-9401
Dietary Supplement: Placebo
Registration Number
NCT03258437
Lead Sponsor
Korean Society for Sexual Medicine and Andrology
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
27
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
DA-9401DA-9401capsules (4cap/d, 2.16 g/d) for 12 weeks.
PlaceboPlaceboPlacebo for 12 weeks.
Primary Outcome Measures
NameTimeMethod
Changes of Sperm motility12 weeks

Changes of sperm profile were assessed before and after the intervention

Secondary Outcome Measures
NameTimeMethod
Changes of Sperm count12 weeks

Changes of Sperm count(X10\^6(M)/ml) profile were assessed before and after the intervention

Changes of Ejaculated pH12 weeks

Changes of Ejaculated pH profile were assessed before and after the intervention

Changes of Sperm morphology12 weeks

Changes of Sperm morphology(%) profile were assessed before and after the intervention

Changes of MFS(Multidimensional Fatigue Scale)12 weeks

Changes of questionnaire profile were assessed before and after the intervention

Changes of Ejaculated volume12 weeks

Changes of Ejaculated volume(ml) profile were assessed before and after the intervention

Changes of hormone(Total testosterone, FSH, LH)12 weeks

Changes of hormone{Total testosterone(ng/ml), FSH and LH(mlU/ml)} profile were assessed before and after the intervention

Changes of IIEF(International Index of Erectile Function)12 weeks

Changes of questionnaire profile were assessed before and after the intervention

Trial Locations

Locations (1)

Chonbuk National University Hospital of urology

🇰🇷

Jeonju, Jeollabuk-do, Korea, Republic of

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