Effectiveness and Safety of Guilu Erxian Oral Liquid in the Treatment of Oligozoospermia and Asth… (NCT07270146) | Clinical Trial Compass
CompletedPhase 4
Effectiveness and Safety of Guilu Erxian Oral Liquid in the Treatment of Oligozoospermia and Asthenospermia With Syndrome of Shen (Kidney) Essence Deficiency
China360 participantsStarted 2022-10-08
Plain-language 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.
Who can participate
Age range22 Years – 40 Years
SexMALE
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Inclusion criteria
✓. 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.
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;