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Shen Hai Long Capsule for Male Asthenospermia

China120 participantsStarted 2023-02-15

Plain-language summary

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

Age range22 Years – 50 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Forward motile sperm ratio (PR)

Timeframe: 12 weeks

NCT IDNCT05745610

SponsorZhongnan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-30

Junhao Lei, Dr.

Who can participate

Age range22 Years – 50 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.