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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Spermatocele

Intervention / Treatment
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* Dietary Supplement: DA-9401
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DA-9401<br>capsules (4cap/d, 2.16 g/d) for 12 weeks. | Dietary Supplement: DA-9401<br> <br> * Other names: capsules (4cap/d, 2.16 g/d) for 12 weeks.;|
| Placebo Comparator: Placebo<br>Placebo for 12 weeks. | Dietary Supplement: Placebo<br>* Placebo for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Sperm motility | 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 | 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 | 12 weeks | 
| Changes of Sperm morphology | Changes of Sperm morphology(%) profile were assessed before and after the intervention | 12 weeks | 
| Changes of Ejaculated pH | Changes of Ejaculated pH profile were assessed before and after the intervention | 12 weeks | 
| 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 | 
| Changes of IIEF(International Index of Erectile Function) | Changes of questionnaire profile were assessed before and after the intervention | 12 weeks | 
| Changes of MFS(Multidimensional Fatigue Scale) | Changes of questionnaire profile were assessed before and after the intervention | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sperm motility, Clinical Trial , DA-9401