Shen Hai Long Capsule for Male Asthenospermia

Not Applicable

Not yet recruiting

• Conditions: Efficacy and Safety of Shen Hai Long Capsule for Mild to Moderate Asthenospermia in Men
• Interventions: Drug: Shen Hai Long Capsule; Drug: Sheng Jing Capsule

• Registration Number: NCT05745610
• Lead Sponsor: Zhongnan Hospital

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.

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-13
• Study Start: 2023-02-15
• Study First Submitted QC: 2023-02-15
• Last Update Submitted: 2023-02-15
• Study First Posted: 2023-02-27
• Last Update Posted: 2023-02-27
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shen Hai Long Group	Shen Hai Long Capsule	-
Sheng Jing Group	Sheng Jing Capsule	-

Primary Outcome Measures

Name	Time	Method
Forward motile sperm ratio (PR)	12 weeks	To compare the PR between baseline and 12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China