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Completed

NCT Number: NCT03258437

Efficacy and Safety of 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.

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Key information

Conditions

Spermatocele Cysts Genital Diseases Genital Diseases, Male Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urogenital Diseases

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Chonbuk National University Hospital of urology

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-9401

Dietary Supplement

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

Placebo

Dietary Supplement

Placebo for 12 weeks.

Primary outcomes

  1. Changes of Sperm motility

    Time frame: 12 weeks

    Changes of sperm profile were assessed before and after the intervention

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Korean Society for Sexual Medicine and Andrology

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 23, 2017
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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