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

March 18, 2018 updated by: Park Jong Kwan, Korean Society for Sexual Medicine and Andrology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
        • Chonbuk National University Hospital of urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo for 12 weeks.
Dietary supplement: Placebo
Placebo for 12 weeks.
Experimental: DA-9401
capsules (4cap/d, 2.16 g/d) for 12 weeks.
Dietary supplement: DA-9401
Other Names:
  • capsules (4cap/d, 2.16 g/d) for 12 weeks.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of Sperm count
Time Frame: 12 weeks
Changes of Sperm count(X10^6(M)/ml) profile were assessed before and after the intervention
12 weeks
Changes of Ejaculated volume
Time Frame: 12 weeks
Changes of Ejaculated volume(ml) profile were assessed before and after the intervention
12 weeks
Changes of Sperm morphology
Time Frame: 12 weeks
Changes of Sperm morphology(%) profile were assessed before and after the intervention
12 weeks
Changes of Ejaculated pH
Time Frame: 12 weeks
Changes of Ejaculated pH profile were assessed before and after the intervention
12 weeks
Changes of hormone(Total testosterone, FSH, LH)
Time Frame: 12 weeks
Changes of hormone{Total testosterone(ng/ml), FSH and LH(mlU/ml)} profile were assessed before and after the intervention
12 weeks
Changes of IIEF(International Index of Erectile Function)
Time Frame: 12 weeks
Changes of questionnaire profile were assessed before and after the intervention
12 weeks
Changes of MFS(Multidimensional Fatigue Scale)
Time Frame: 12 weeks
Changes of questionnaire profile were assessed before and after the intervention
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korean Society for Sexual Medicine and Andrology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2016

Primary Completion (Actual)

January 30, 2018

Study Completion (Actual)

January 30, 2018

Study Registration Dates

First Submitted

July 5, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (Actual)

August 23, 2017

Study Record Updates

Last Update Posted (Actual)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 18, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA-9401-SM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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