Shen Hai Long Capsule for Male Asthenospermia

Launched by ZHONGNAN HOSPITAL · Feb 15, 2023

Keywords

ClinConnect Summary

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.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Age range from 22 to 50 years old;
• • 2. 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;
• • 3. At least two standard semen analyses indicated that sperm concentration ≥15×106 /ml; Sperm normal morphology rate ≥4%;
• • 4. No other Chinese and Western drugs for the treatment of oligospermia, weak and malformed spermia have been taken in the past 3 months;
• • 5. The subject voluntarily participates and signs the informed consent.
• Exclusion Criteria:
• • 1. Varicocele, ejaculatory duct/seminal vesicle cyst, anti-sperm antibody (+);
• • 2. Genital tract infection: seminal plasmic elastase \> 1000ng/ml or leukocyte semen disease (peroxidase positive cell concentration in semen more than 1×10\^6/mL);
• • 3. Erectile dysfunction, ejaculation disorders;
• • 4. 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);
• • 5. Patients with allergic history or constitution to therapeutic drugs;
• • 6. Patients who have taken drugs affecting the study within 3 months, such as antitumor and antiepileptic drugs, etc.