Effectiveness and Safety of Guilu Erxian Oral Liquid in the Treatment of Oligozoospermia and Asthenospermia With Syndrome of Shen (Kidney) Essence Deficiency

NCT ID: NCT07270146

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-08
• Study Completion Date: 2025-02-10

Brief 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. 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.

Conditions

Mild and Moderate Oligozoospermia Asthenospermia or Oligoasthenospermia and the Syndrome Differentiation Type is Shen (Kidney) Essence Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Guilu Erxian Oral Liquid

Group Type: EXPERIMENTAL

Guilu Erxian Oral Liquid

Intervention Type: DRUG

Guilu Erxian Oral Liquid+Wuzi Yanzong Oral Liquid Simulator

Wuzi Yanzong oral liquid

Group Type: ACTIVE_COMPARATOR

Wuzi Yanzong oral liquid

Intervention Type: DRUG

Wuzi Yanzong oral liquid+Guilu Erxian oral liquid simulator

Interventions

Guilu Erxian Oral Liquid

Guilu Erxian Oral Liquid+Wuzi Yanzong Oral Liquid Simulator

Intervention Type: DRUG

Wuzi Yanzong oral liquid

Wuzi Yanzong oral liquid+Guilu Erxian oral liquid simulator

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Married men aged 22 to 40;

2. Meet the diagnostic criteria of male infertility;

3. Meet the diagnostic criteria for mild and moderate oligozoospermia, asthenospermia and oligoasthenospermia;

4. Meet the TCM syndrome differentiation standard of Shen (kidney) essence deficiency syndrome;

5. Sign the informed consent form voluntarily.

Exclusion Criteria

1. Infertility due to chromosome abnormalities (such as Roche heterotopia, Y chromosome microdeletion, etc.);

2. Varicocele or cryptorchidism;

3. Diseases affecting semen quality such as orchitis, epididymitis, mycoplasma and chlamydia infection;

4. Anejaculation, retrograde ejaculation and other sexual dysfunction;

5. 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;

6. Hypertension (systolic blood pressure > 160 mmHg and / or diastolic blood pressure > 100 mmHg) or diabetes (fasting blood glucose > 7mmol / L) with poor drug control;

7. Serious mental illness, accompanied by mental disorder or loss of self-care ability;

8. Those who are allergic to the test drug;

9. 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;

10. Those who have been unable to take the test drug in the past or have intolerable adverse reactions;

11. Those who used drugs to improve or affect sperm concentration or motility 1 month before screening;

12. Those who have participated in other clinical trials within 3 months before screening;

13. According to the judgment of the investigator, there are other persons who are not suitable to participate in this clinical trial.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

DongE E Jiao Coporation Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xi Yuan Hospital of China Academy of Chinese Medical Sciences

Beijing, , China

Countries

China

Other Identifiers

DEEJ-CTP-20220129

Identifier Type: -

Identifier Source: org_study_id