Efficacy and Safety of Shen Hai Long Capsule for Mild to Moderate Asthenospermia in Men
Conditions
Keywords
efficacy, safety
Brief summary
To evaluate the efficacy and safety of Shen Hai Long Capsule in the treatment of mild to moderate asthenospermia in men.
Detailed 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.
Interventions
DRUGShen Hai Long Capsule
3 times/day (9 capsules/day) for 12 weeks
DRUGSheng Jing Capsule
3 times/day (12 capsules/day) for 12 weeks
Sponsors
Zhongnan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
22 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forward motile sperm ratio (PR) | 12 weeks | To compare the PR between baseline and 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sperm survival rate | 12 weeks | To compare the Sperm survival rate between baseline and 12 weeks |
| Sperm concentration | 12 weeks | To compare the Sperm concentration between baseline and 12 weeks |
Countries
China
Contacts
Primary ContactJunhao Lei, Dr.
Outcome results
None listed