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

Spermatocele Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03258437
• Other study ID #: DA-9401-SM
• Status: Completed
• Phase: N/A
• First received: July 5, 2017
• Last updated: March 18, 2018
• Start date: April 12, 2016
• Est. completion date: January 30, 2018

Study information

• Verified date: March 2018
• Source: Korean Society for Sexual Medicine and Andrology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 30, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Spermatocele

Intervention

Dietary Supplement:
• DA-9401

• Placebo
Placebo for 12 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital of urology	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Korean Society for Sexual Medicine and Andrology

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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