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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guilu Erxian Oral Liquid | Experimental |
| |
| Wuzi Yanzong oral liquid | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guilu Erxian Oral Liquid | Drug | Guilu Erxian Oral Liquid+Wuzi Yanzong Oral Liquid Simulator |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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;
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:
â‘ History of smoking: Those who have smoked more than 5 cigarettes per day in the past 6 months;
â‘¡History 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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xi Yuan Hospital of China Academy of Chinese Medical Sciences | Beijing | China |
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| Wuzi Yanzong oral liquid | Drug | Wuzi Yanzong oral liquid+Guilu Erxian oral liquid simulator |
|
| 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 |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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