Efficacy and Safety of DA-9401 on Improvement of Sperm Mo... | NCT03258437

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

NCT03258437

Sponsor

Korean Society for Sexual Medicine and Andrology

Status

Completed

Last Update Posted

Mar 20, 2018Actual

Enrollment

27Actual

Phase

Not Applicable

Conditions

Spermatocele

Interventions

DA-9401
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2016Actual

Primary Completion Date

Jan 30, 2018Actual

Completion Date

Jan 30, 2018Actual

First Submitted Date

Jul 5, 2017

First Submission Date that Met QC Criteria

Aug 21, 2017

First Posted Date

Aug 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2018

Last Update Posted Date

Mar 20, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Park Jong Kwan, Principal Investigator, Chonbuk National University Hospital, Urology, Korean Society for Sexual Medicine and AndrologyPrincipal Investigator

Lead Sponsor

Korean Society for Sexual Medicine and AndrologyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
DA-9401	Dietary Supplement		DA-9401	capsules (4cap/d, 2.16 g/d) for 12 weeks.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes of Sperm motility	Changes of sperm profile were assessed before and after the intervention	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes of Sperm count	Changes of Sperm count(X10^6(M)/ml) profile were assessed before and after the intervention	12 weeks
Changes of Ejaculated volume	Changes of Ejaculated volume(ml) profile were assessed before and after the intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chonbuk National University Hospital of urology		Jeonju	Jeollabuk-do	560-822	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013088	Spermatocele

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000627788	DA-9401

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided