NCT03258437

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

1.8 years

First QC Date

July 5, 2017

Last Update Submit

March 18, 2018

Conditions

Spermatocele

Keywords

sperm motility, Clinical Trial , DA-9401

Outcome Measures

Primary Outcomes (1)

  • Changes of Sperm motility

    Changes of sperm profile were assessed before and after the intervention

    12 weeks

Secondary Outcomes (7)

  • Changes of Sperm count

    12 weeks

  • Changes of Ejaculated volume

    12 weeks

  • Changes of Sperm morphology

    12 weeks

  • Changes of Ejaculated pH

    12 weeks

  • Changes of hormone(Total testosterone, FSH, LH)

    12 weeks

  • +2 more secondary outcomes

Study Arms (2)

DA-9401

EXPERIMENTAL

capsules (4cap/d, 2.16 g/d) for 12 weeks.

Dietary Supplement: DA-9401

Placebo

PLACEBO COMPARATOR

Placebo for 12 weeks.

Dietary Supplement: Placebo

Interventions

DA-9401DIETARY_SUPPLEMENT
Also known as: capsules (4cap/d, 2.16 g/d) for 12 weeks.
DA-9401
PlaceboDIETARY_SUPPLEMENT

Placebo for 12 weeks.

Placebo

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20-55 years
  • sperm motility 40\~69%

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonbuk National University Hospital of urology

Jeonju, Jeollabuk-do, 560-822, South Korea

Location

MeSH Terms

Conditions

Spermatocele

Interventions

DA-9401

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesCystsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Chonbuk National University Hospital, Urology

Study Record Dates

First Submitted

July 5, 2017

First Posted

August 23, 2017

Study Start

April 12, 2016

Primary Completion

January 30, 2018

Study Completion

January 30, 2018

Last Updated

March 20, 2018

Record last verified: 2018-03

Locations

KR(1)