Shen Hai Long Capsule for Male Asthenospermia

• Sponsor: Zhongnan Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05745610
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 22.5
• Patients Per Site Per Month: 5.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Efficacy and Safety of Shen Hai Long Capsule for Mild to Moderate Asthenospermia in Men	Drug: Shen Hai Long Capsule; Drug: Sheng Jing Capsule	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Clinical Trial on the Efficacy and Safety of Shen Hai Long Capsule in the Treatment of Male Asthenospermia
• Anticipated Study Start Date: Feb 15, 2023
• Anticipated Primary Completion Date: Jun 30, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Shen Hai Long Group	Drug: Shen Hai Long Capsule; 3 times/day (9 capsules/day) for 12 weeks
Active Comparator: Sheng Jing Group	Drug: Sheng Jing Capsule; 3 times/day (12 capsules/day) for 12 weeks

Outcome Measures

Primary Outcome Measures

1. Forward motile sperm ratio (PR) [12 weeks]

   To compare the PR between baseline and 12 weeks

Secondary Outcome Measures

1. Sperm survival rate [12 weeks]

   To compare the Sperm survival rate between baseline and 12 weeks

2. Sperm concentration [12 weeks]

   To compare the Sperm concentration between baseline and 12 weeks

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongnan Hospital of Wuhan University	Wuhan	Hubei	China

Sponsors and Collaborators

• Zhongnan Hospital

Investigators

• Principal Investigator: Yuanzhen Zhang, Prof., Wuhan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuanzhen Zhang, Prof, Zhongnan Hospital
• ClinicalTrials.gov Identifier: NCT05745610
• Other Study ID Numbers: Shenhailong2023
• First Posted: Feb 27, 2023
• Last Update Posted: Feb 27, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yuanzhen Zhang, Prof, Zhongnan Hospital: efficacy; safety
• Additional relevant MeSH terms: Asthenozoospermia

Study Results

No Results Posted as of Feb 27, 2023