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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03258437
Recruitment Status : Completed
First Posted : August 23, 2017
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Park Jong Kwan, 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.

Condition or disease Intervention/treatment Phase
Spermatocele Dietary Supplement: DA-9401 Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : April 12, 2016
Actual Primary Completion Date : January 30, 2018
Actual Study Completion Date : January 30, 2018

Arm Intervention/treatment
Experimental: DA-9401
capsules (4cap/d, 2.16 g/d) for 12 weeks.
Dietary Supplement: DA-9401
Other Name: capsules (4cap/d, 2.16 g/d) for 12 weeks.

Placebo Comparator: Placebo
Placebo for 12 weeks.
Dietary Supplement: Placebo
Placebo for 12 weeks.




Primary Outcome Measures :
  1. Changes of Sperm motility [ Time Frame: 12 weeks ]
    Changes of sperm profile were assessed before and after the intervention


Secondary Outcome Measures :
  1. Changes of Sperm count [ Time Frame: 12 weeks ]
    Changes of Sperm count(X10^6(M)/ml) profile were assessed before and after the intervention

  2. Changes of Ejaculated volume [ Time Frame: 12 weeks ]
    Changes of Ejaculated volume(ml) profile were assessed before and after the intervention

  3. Changes of Sperm morphology [ Time Frame: 12 weeks ]
    Changes of Sperm morphology(%) profile were assessed before and after the intervention

  4. Changes of Ejaculated pH [ Time Frame: 12 weeks ]
    Changes of Ejaculated pH profile were assessed before and after the intervention

  5. 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

  6. Changes of IIEF(International Index of Erectile Function) [ Time Frame: 12 weeks ]
    Changes of questionnaire profile were assessed before and after the intervention

  7. Changes of MFS(Multidimensional Fatigue Scale) [ Time Frame: 12 weeks ]
    Changes of questionnaire profile were assessed before and after the intervention



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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258437


Locations
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Korea, Republic of
Chonbuk National University Hospital of urology
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Sponsors and Collaborators
Korean Society for Sexual Medicine and Andrology
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Responsible Party: Park Jong Kwan, Principal Investigator, Chonbuk National University Hospital, Urology, Korean Society for Sexual Medicine and Andrology
ClinicalTrials.gov Identifier: NCT03258437    
Other Study ID Numbers: DA-9401-SM
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Park Jong Kwan, Korean Society for Sexual Medicine and Andrology:
sperm motility, Clinical Trial , DA-9401
Additional relevant MeSH terms:
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Spermatocele
Cysts
Pathological Conditions, Anatomical