Efficacy and Safety of Shen Hai Long Capsule for Mild to Moderate Asthenospermia in MenNCT05745610
Shen Hai Long Capsule for Male Asthenospermia
A study testing Shen Hai Long Capsule and Sheng Jing Capsule in people with Efficacy and Safety of Shen Hai Long Capsule for Mild to Moderate Asthenospermia in Men, run by Zhongnan Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Shen Hai Long Capsule in the treatment of mild to moderate asthenospermia in men. Read more about this study
- Who is it for?
- Ages 22 to 50 years, men only
- Conditions the study is for
- Efficacy and Safety of Shen Hai Long Capsule for Mild to Moderate Asthenospermia in Men
- What is being tested?
- Shen Hai Long Capsule and Sheng Jing Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Clinical Trial on the Efficacy and Safety of Shen Hai Long Capsule in the Treatment of Male Asthenospermia
To evaluate the efficacy and safety of Shen Hai Long Capsule in the treatment of mild to moderate asthenospermia in men.
Read the 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.
- Being tested
- Shen Hai Long Capsule, Sheng Jing Capsule
- Keywords
- efficacy, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shen Hai Long CapsuleDrug
3 times/day (9 capsules/day) for 12 weeks
Sheng Jing CapsuleDrug
3 times/day (12 capsules/day) for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Shen Hai Long Group | Experimental | Not described Receives: Drug: Shen Hai Long Capsule |
| Sheng Jing Group | Active comparator | Not described Receives: Drug: Sheng Jing Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forward motile sperm ratio (PR)
To compare the PR between baseline and 12 weeks
Measured: 12 weeks
Secondary outcomes (2)
Sperm survival rate
To compare the Sperm survival rate between baseline and 12 weeks
Measured: 12 weeks
Sperm concentration
To compare the Sperm concentration between baseline and 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start15 Feb 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy and Safety of Shen Hai Long Capsule for Mild to Moderate Asthenospermia in MenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuanzhen Zhang, Zhongnan Hospital
- Investigators
- Yuanzhen Zhang, Prof., Principal investigator, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745610
- Sponsor's protocol ID
- Shenhailong2023
- Status last verified
- Feb 2023
- First submitted
- 13 Feb 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Please contact the Central Contact Person for detailed study data.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Clinical Trial on the Efficacy and Safety of Shen Hai Long Capsule in the Treatment of Male Asthenospermia
- ClinicalTrials.gov ID
- NCT05745610
- Acronym / sponsor ID
- Shenhailong2023
- Keywords
- efficacy, safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 15 Feb 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shen Hai Long Group | Experimental | Drug: Shen Hai Long Capsule |
| Sheng Jing Group | Active comparator | Drug: Sheng Jing Capsule |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shen Hai Long Capsule3 times/day (9 capsules/day) for 12 weeks | Drug | Shen Hai Long Group |
| Sheng Jing Capsule3 times/day (12 capsules/day) for 12 weeks | Drug | Sheng Jing Group |
Primary outcome
Forward motile sperm ratio (PR)
Time frame: 12 weeks
To compare the PR between baseline and 12 weeks
2 secondary outcomes
Sperm survival rate
Time frame: 12 weeks
Sperm concentration
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Individual participant dataSharing planned: No. Please contact the Central Contact Person for detailed study data.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuanzhen Zhang, Prof. principal investigator
Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shen Hai Long Capsule and Sheng Jing Capsule in people with Efficacy and Safety of Shen Hai Long Capsule for Mild to Moderate Asthenospermia in Men, run by Zhongnan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junhao Lei, Dr. (+86-27-13697326659, Lei_junhao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forward motile sperm ratio (PR) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.