Shen Hai Long Capsule for Male Asthenospermia

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of Shen Hai Long Capsule in the treatment of mild to moderate asthenospermia in men.

Detailed Description
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To evaluate the efficacy and safety of Shen Hai Long Capsule in the treatment of mild to moderate asthenospermia in men: 1) Efficacy index (1) Main efficacy indexes Forward motile sperm ratio (PR) (2) Secondary efficacy indexes 1. Sperm survival rate; 2. Sperm concentration; 3. Normal morphology rate of sperm; 4. Seminal malondialdehyde (MDA) 5. Seminal superoxide dismutase (SOD) 2) Safety indicators (1) Vital signs; (2) liver and kidney function; (3) blood routine; (4) electrocardiogram; (5) Adverse events.

Official Title
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An Clinical Trial on the Efficacy and Safety of Shen Hai Long Capsule in the Treatment of Male Asthenospermia

Conditions
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Efficacy and Safety of Shen Hai Long Capsule for Mild to Moderate Asthenospermia in Men

Intervention / Treatment
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* Drug: Shen Hai Long Capsule
* Drug: Sheng Jing Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range from 22 to 50 years old; Patients with mild to moderate asthenospermia, that is, at least two normative semen analyses indicated that 10%≤PR percentage < 32% and the total number of PR sperm ranged from 5 million to 20 million; At least two standard semen analyses indicated that sperm concentration ≥15×106 /ml; Sperm normal morphology rate ≥4%; No other Chinese and Western drugs for the treatment of oligospermia, weak and malformed spermia have been taken in the past 3 months; The subject voluntarily participates and signs the informed consent. Exclusion Criteria: Varicocele, ejaculatory duct/seminal vesicle cyst, anti-sperm antibody (+); Genital tract infection: seminal plasmic elastase > 1000ng/ml or leukocyte semen disease (peroxidase positive cell concentration in semen more than 1×10^6/mL); Erectile dysfunction, ejaculation disorders; suffer from mental disorders, immune system diseases; Severe impairment of liver and kidney function (serum transaminase ≥2× upper limit of medical reference value, creatinine clearance ≤40ml/min or active stage of chronic kidney disease); Patients with allergic history or constitution to therapeutic drugs; Patients who have taken drugs affecting the study within 3 months, such as antitumor and antiepileptic drugs, etc.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shen Hai Long Group<br> | Drug: Shen Hai Long Capsule<br>* 3 times/day (9 capsules/day) for 12 weeks<br>|
| Active Comparator: Sheng Jing Group<br> | Drug: Sheng Jing Capsule<br>* 3 times/day (12 capsules/day) for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forward motile sperm ratio (PR) | To compare the PR between baseline and 12 weeks | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm survival rate | To compare the Sperm survival rate between baseline and 12 weeks | 12 weeks | 
| Sperm concentration | To compare the Sperm concentration between baseline and 12 weeks | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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efficacy, safety