Shen Hai Long Capsule for Male Asthenospermia

Zhongnan Hospital

Status: Not yet enrolling

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

Treatments: Drug: Shen Hai Long Capsule; Drug: Sheng Jing Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT05745610

Shenhailong2023

Details and patient eligibility

About

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

Full description

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.

Enrollment: 120 estimated patients

Sex: Male

Ages: 22 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Shen Hai Long Group

Experimental group

Treatment:

Drug: Shen Hai Long Capsule

Sheng Jing Group

Active Comparator group

Treatment:

Drug: Sheng Jing Capsule