Mild and Moderate Oligozoospermia Asthenospermia or Oligoasthenospermia and the Syndrome Differentiation Type is Shen (Kidney) Essence DeficiencyPhase 4NCT07270146
Effectiveness and Safety of Guilu Erxian Oral Liquid in the Treatment of Oligozoospermia and Asthenospermia With Syndrome of Shen (Kidney) Essence Deficiency
A Phase 4 study testing Guilu Erxian Oral Liquid and Wuzi Yanzong oral liquid in people with Mild and Moderate Oligozoospermia Asthenospermia or Oligoasthenospermia and the Syndrome Differentiation Type is Shen (Kidney) Essence Deficiency, run by DongE E Jiao Coporation Limited at 1 site in China.
Trial summary
The main function of Guilu Erxian Oral Liquid is to warm the shen (kindney) and replenish essence. It is used for chronic shen (kindney) deficiency, waist and knee weakness, spermatorrhea and impotence. Read more about this study
- Who is it for?
- Ages 22 to 40 years, men only
- Conditions the study is for
- Mild and Moderate Oligozoospermia Asthenospermia or Oligoasthenospermia and the Syndrome Differentiation Type is Shen (Kidney) Essence Deficiency
- What is being tested?
- Guilu Erxian Oral Liquid and Wuzi Yanzong oral liquid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2022to 10 Feb 2025
- Phase
- Phase 4
- 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 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Married men aged 22 to 40;
- Meet the diagnostic criteria of male infertility;
- Meet the diagnostic criteria for mild and moderate oligozoospermia, asthenospermia and oligoasthenospermia;
- Meet the TCM syndrome differentiation standard of Shen (kidney) essence deficiency syndrome;
- Sign the informed consent form voluntarily.
Who cannot join
- Infertility due to chromosome abnormalities (such as Roche heterotopia, Y chromosome microdeletion, etc.);
- Varicocele or cryptorchidism;
- Diseases affecting semen quality such as orchitis, epididymitis, mycoplasma and chlamydia infection;
- Anejaculation, retrograde ejaculation and other sexual dysfunction;
- Severe liver and kidney dysfunction (alanine aminotransferase (ALT)>1.5 × ULN, aspartate aminotransferase (AST)>1.5 × ULN, blood urea nitrogen (BUN)>2 × ULN, Cr>1 × ULN), disease of cardiovascular and cerebrovascular system, disease of hematopoietic system;
- Hypertension (systolic blood pressure > 160 mmHg and / or diastolic blood pressure > 100 mmHg) or diabetes (fasting blood glucose > 7mmol / L) with poor drug control;
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- Serious mental illness, accompanied by mental disorder or loss of self-care ability;
- Those who are allergic to the test drug;
- Those who have long term bad habits such as smoking and drinking, which may affect fertility, or those who cannot ban smoking and drinking during the test, the specific criteria are as follows:
- ①History of smoking: Those who have smoked more than 5 cigarettes per day in the past 6 months;
- ②History of drinking: in the past 6 months, the average daily consumption of alcohol exceeded the following standards: 570 ml of beer, 200 ml of wine or 60 ml of spirit, each containing about 20 g of alcohol;
- Those who have been unable to take the test drug in the past or have intolerable adverse reactions;
- Those who used drugs to improve or affect sperm concentration or motility 1 month before screening;
- Those who have participated in other clinical trials within 3 months before screening;
- According to the judgment of the investigator, there are other persons who are not suitable to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Xi Yuan Hospital of China Academy of Chinese Medical Sciences
Beijing
About this study
Official title: A Multicenter, Randomized, Double-blind, Positive Drug Controlled Clinical Trial on the Efficacy and Safety of Guilu Erxian Oral Liquid in the Treatment of Oligozoospermia and Asthenospermia With Syndrome of Shen (Kidney) Essence Deficiency
The main function of Guilu Erxian Oral Liquid is to warm the shen (kindney) and replenish essence. It is used for chronic shen (kindney) deficiency, waist and knee weakness, spermatorrhea and impotence. The treatment of deficiency of kidney essence and asthenospermia is to invigorate the shen (kindney) and replenish the essence, nourish the shen (kindney) and assist the essence. The idea of combining traditional Chinese and western medicine is to move the yang and calm the yin, and traditional Chinese medicine is mainly to invigorate the shen (kindney) and replenish the essence. In order to better provide the basis for clinical medication and meet the treatment needs of oligozoospermia and asthenospermia, this trial is intended to evaluate the effectiveness and safety of Guilu Erxian oral liquid in treating oligozoospermia and asthenospermia with Syndrome of Shen (Kidney) Essence Deficiency subjects.
- Being tested
- Guilu Erxian Oral Liquid, Wuzi Yanzong oral liquid
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guilu Erxian Oral LiquidDrug
Guilu Erxian Oral Liquid+Wuzi Yanzong Oral Liquid Simulator
Wuzi Yanzong oral liquidDrug
Wuzi Yanzong oral liquid+Guilu Erxian oral liquid simulator
| Study group | Role | What they receive |
|---|---|---|
| Guilu Erxian Oral Liquid | Experimental | Not described Receives: Drug: Guilu Erxian Oral Liquid |
| Wuzi Yanzong oral liquid | Active comparator | Not described Receives: Drug: Wuzi Yanzong oral liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of anterograde motile sperm (TPMSC)
Total number of anterograde motile sperm (TPMSC), the change value from the baseline
Measured: 4,8,12 weeks after medical treatment
Secondary outcomes (5)
Semen routine parameters: sperm concentration (SC), total sperm count (SPE-C), percentage of sperm forward movement (PR,%), total sperm vitality (PR+NP,%)
Semen routine parameters: sperm concentration (SC), total sperm count (SPE-C), percentage of sperm forward movement (PR,%), total sperm vitality (PR+NP,%), changes from baseline
Measured: 4,8,12 weeks after medical treatment
TCM syndrome score
TCM syndrome score: the change value from the baseline
Measured: 4,8,12 weeks after medical treatment
Pregnancy rate of spouse/partner
Pregnancy rate of the subject's spouse/partner
Measured: 4,8,12,24 weeks after medical treatment
Male reproductive endocrine hormones: testosterone (T), follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL)
Male reproductive endocrine hormones: testosterone (T), follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), the change value compared with the baseline (when it is conditional and necessary to conduct male reproductive endocrine hormone testing)
Measured: 12 weeks after medical treatment
Sperm DNA fragment index, which is used for sperm DNA integrity analysis
Sperm DNA fragment index, which is used for sperm DNA integrity analysis, the change value compared with the baseline (when DFI detection is conditional and necessary)
Measured: 12 weeks after medical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start8 Oct 2022
- Primary completion10 Feb 2025
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild and Moderate Oligozoospermia Asthenospermia or Oligoasthenospermia and the Syndrome Differentiation Type is Shen (Kidney) Essence DeficiencyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- DongE E Jiao Coporation Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270146
- Sponsor's protocol ID
- DEEJ-CTP-20220129
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Positive Drug Controlled Clinical Trial on the Efficacy and Safety of Guilu Erxian Oral Liquid in the Treatment of Oligozoospermia and Asthenospermia With Syndrome of Shen (Kidney) Essence Deficiency
- ClinicalTrials.gov ID
- NCT07270146
- Acronym / sponsor ID
- DEEJ-CTP-20220129
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- DongE E Jiao Coporation LimitedIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2022 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 8 Dec 2025 (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.
The main function of Guilu Erxian Oral Liquid is to warm the shen (kindney) and replenish essence. It is used for chronic shen (kindney) deficiency, waist and knee weakness, spermatorrhea and impotence. The treatment of deficiency of kidney essence and asthenospermia is to invigorate the shen (kindney) and replenish the essence, nourish the shen (kindney) and assist the essence. The idea of combining traditional Chinese and western medicine is to move the yang and calm the yin, and traditional Chinese medicine is mainly to invigorate the shen (kindney) and replenish the essence. In order to better provide the basis for clinical medication and meet the treatment needs of oligozoospermia and asthenospermia, this trial is intended to evaluate the effectiveness and safety of Guilu Erxian oral liquid in treating oligozoospermia and asthenospermia with Syndrome of Shen (Kidney) Essence Deficiency subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guilu Erxian Oral Liquid | Experimental | Drug: Guilu Erxian Oral Liquid |
| Wuzi Yanzong oral liquid | Active comparator | Drug: Wuzi Yanzong oral liquid |
Who may qualify
- Ages
- 22 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Married men aged 22 to 40;
- Meet the diagnostic criteria of male infertility;
- Meet the diagnostic criteria for mild and moderate oligozoospermia, asthenospermia and oligoasthenospermia;
- Meet the TCM syndrome differentiation standard of Shen (kidney) essence deficiency syndrome;
- Sign the informed consent form voluntarily.
Key exclusion criteria (15 listed)
- Infertility due to chromosome abnormalities (such as Roche heterotopia, Y chromosome microdeletion, etc.);
- Varicocele or cryptorchidism;
- Diseases affecting semen quality such as orchitis, epididymitis, mycoplasma and chlamydia infection;
- Anejaculation, retrograde ejaculation and other sexual dysfunction;
- Severe liver and kidney dysfunction (alanine aminotransferase (ALT)>1.5 × ULN, aspartate aminotransferase (AST)>1.5 × ULN, blood urea nitrogen (BUN)>2 × ULN, Cr>1 × ULN), disease of cardiovascular and cerebrovascular system, disease of hematopoietic system;
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 |
|---|---|---|
| Guilu Erxian Oral LiquidGuilu Erxian Oral Liquid+Wuzi Yanzong Oral Liquid Simulator | Drug | Guilu Erxian Oral Liquid |
| Wuzi Yanzong oral liquidWuzi Yanzong oral liquid+Guilu Erxian oral liquid simulator | Drug | Wuzi Yanzong oral liquid |
Primary outcome
Total number of anterograde motile sperm (TPMSC)
Time frame: 4,8,12 weeks after medical treatment
Total number of anterograde motile sperm (TPMSC), the change value from the baseline
5 secondary outcomes
Semen routine parameters: sperm concentration (SC), total sperm count (SPE-C), percentage of sperm forward movement (PR,%), total sperm vitality (PR+NP,%)
Time frame: 4,8,12 weeks after medical treatment
TCM syndrome score
Time frame: 4,8,12 weeks after medical treatment
Pregnancy rate of spouse/partner
Time frame: 4,8,12,24 weeks after medical treatment
Male reproductive endocrine hormones: testosterone (T), follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL)
Time frame: 12 weeks after medical treatment
Sperm DNA fragment index, which is used for sperm DNA integrity analysis
Time frame: 12 weeks after medical treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Guilu Erxian Oral Liquid and Wuzi Yanzong oral liquid in people with Mild and Moderate Oligozoospermia Asthenospermia or Oligoasthenospermia and the Syndrome Differentiation Type is Shen (Kidney) Essence Deficiency, run by DongE E Jiao Coporation Limited 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 15 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: finished, as of the sponsor's last update on 8 Dec 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of anterograde motile sperm (TPMSC) (time frame: 4,8,12 weeks after medical treatment). 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 8 Dec 2025.