Shen Hai Long Capsule for Male Asthenospermia

NCT ID: NCT05745610

Last Updated: 2023-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Shen Hai Long Group

Group Type EXPERIMENTAL

Shen Hai Long Capsule

Intervention Type DRUG

3 times/day (9 capsules/day) for 12 weeks

Sheng Jing Group

Group Type ACTIVE_COMPARATOR

Sheng Jing Capsule

Intervention Type DRUG

3 times/day (12 capsules/day) for 12 weeks

Interventions

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Shen Hai Long Capsule

3 times/day (9 capsules/day) for 12 weeks

Intervention Type DRUG

Sheng Jing Capsule

3 times/day (12 capsules/day) for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

22 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Zhongnan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yuanzhen Zhang

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuanzhen Zhang, Prof.

Role: PRINCIPAL_INVESTIGATOR

Wuhan University

Locations

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Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Site Status

Countries

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China

Central Contacts

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Junhao Lei, Dr.

Role: CONTACT

+86-27-13697326659

Other Identifiers

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Shenhailong2023

Identifier Type: -

Identifier Source: org_study_id

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