NCT07270146CompletedPhase 4
Effectiveness and Safety of Guilu Erxian Oral Liquid in the Treatment of Oligozoospermia and Asthenospermia With Syndrome of Shen (Kidney) Essence Deficiency
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
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 360 (actual)
- First submitted
- 24 Nov 2025
- Start date
- 8 Oct 2022
- Primary completion date
- 10 Feb 2025
- Lead sponsor
- DongE E Jiao Coporation Limited
- NCT number
- NCT07270146
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 360
- From 8 Oct 2022 to the primary completion date, 10 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Diseases affecting semen quality such as orchitis, epididymitis, mycoplasma and chlamydia infection;
- 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;
Lab values
- 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;
Other
- Infertility due to chromosome abnormalities (such as Roche heterotopia, Y chromosome microdeletion, etc.);
- Varicocele or cryptorchidism;
- Anejaculation, retrograde ejaculation and other sexual dysfunction;
- According to the judgment of the investigator, there are other persons who are not suitable to participate in this clinical trial.
Who the study is looking for
- 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.
Age in the registry: 22 years to 40 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xi Yuan Hospital of China Academy of Chinese Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.