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Shen Hai Long Capsule for Male Asthenospermia

Z

Zhongnan Hospital

Status

Not yet enrolling

Conditions

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

Treatments

Drug: Shen Hai Long Capsule
Drug: Sheng Jing Capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT05745610
Shenhailong2023

Details and patient eligibility

About

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

Full 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.

Enrollment

120 estimated patients

Sex

Male

Ages

22 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Shen Hai Long Group
Experimental group
Treatment:
Drug: Shen Hai Long Capsule
Sheng Jing Group
Active Comparator group
Treatment:
Drug: Sheng Jing Capsule

Trial contacts and locations

1

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Central trial contact

Junhao Lei, Dr.

Data sourced from clinicaltrials.gov

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