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Shen Hai Long Capsule for Male Asthenospermia

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Shen Hai Long Capsule
Sheng Jing Capsule
Sponsored by
Zhongnan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Efficacy and Safety of Shen Hai Long Capsule for Mild to Moderate Asthenospermia in Men focused on measuring efficacy, safety

Eligibility Criteria

22 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Zhongnan Hospital of Wuhan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Shen Hai Long Group

Sheng Jing Group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Sperm survival rate
To compare the Sperm survival rate between baseline and 12 weeks
Sperm concentration
To compare the Sperm concentration between baseline and 12 weeks

Full Information

First Posted
February 13, 2023
Last Updated
February 15, 2023
Sponsor
Zhongnan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05745610
Brief Title
Shen Hai Long Capsule for Male Asthenospermia
Official Title
An Clinical Trial on the Efficacy and Safety of Shen Hai Long Capsule in the Treatment of Male Asthenospermia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 15, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongnan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Efficacy and Safety of Shen Hai Long Capsule for Mild to Moderate Asthenospermia in Men
Keywords
efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Shen Hai Long Group
Arm Type
Experimental
Arm Title
Sheng Jing Group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Shen Hai Long Capsule
Intervention Description
3 times/day (9 capsules/day) for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Sheng Jing Capsule
Intervention Description
3 times/day (12 capsules/day) for 12 weeks
Primary Outcome Measure Information:
Title
Forward motile sperm ratio (PR)
Description
To compare the PR between baseline and 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Sperm survival rate
Description
To compare the Sperm survival rate between baseline and 12 weeks
Time Frame
12 weeks
Title
Sperm concentration
Description
To compare the Sperm concentration between baseline and 12 weeks
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junhao Lei, Dr.
Phone
+86-27-13697326659
Email
Lei_junhao@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuanzhen Zhang, Prof.
Organizational Affiliation
Wuhan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Please contact the Central Contact Person for detailed study data.

Learn more about this trial

Shen Hai Long Capsule for Male Asthenospermia

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