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

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 Overview

• Status: Completed
• Conditions: Mild and Moderate Oligozoospermia Asthenospermia or Oligoasthenospermia and the Syndrome Differentiation Type is Shen (Kidney) Essence Deficiency
• Intervention / Treatment: Drug: Guilu Erxian Oral Liquid; Drug: Wuzi Yanzong oral liquid

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Xi Yuan Hospital of China Academy of Chinese Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guilu Erxian Oral Liquid	Drug: Guilu Erxian Oral Liquid; Guilu Erxian Oral Liquid+Wuzi Yanzong Oral Liquid Simulator
Active Comparator: Wuzi Yanzong oral liquid	Drug: Wuzi Yanzong oral liquid; Wuzi Yanzong oral liquid+Guilu Erxian oral liquid simulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of anterograde motile sperm (TPMSC)	Total number of anterograde motile sperm (TPMSC), the change value from the baseline	4,8,12 weeks after medical treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4,8,12 weeks after medical treatment
TCM syndrome score	TCM syndrome score: the change value from the baseline	4,8,12 weeks after medical treatment
Pregnancy rate of spouse/partner	Pregnancy rate of the subject's spouse/partner	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)	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)	12 weeks after medical treatment

Collaborators and Investigators

• Sponsor: DongE E Jiao Coporation Limited

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2022
• Primary Completion (Actual): February 10, 2025
• Study Completion (Actual): February 10, 2025

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Follicular
• Other Study ID Numbers: DEEJ-CTP-20220129

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No