NCT05320536

A Clinical Study of Gulingji Capsule in the Treatment of Idiopathic Oligospermia, Asthenia, and Teratozoospermia

A Randomized, Double-blind, Placebo-controlled Multicenter Clinical Study of Gulingji Capsule in the Treatment of Idiopathic Oligospermia, Asthenia, and Teratozoospermia.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Jinling Hospital, China · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The object of study for patients with idiopathic disease of OAT, the use of multicenter, randomized, double-blind, controlled, prospective clinical research, choose according to row, standard units of idiopathic male infertility clinics less weak abnormal sperm, randomly divided into experimental group and the placebo group, the comparison between the two groups of patients and semen parameters before and after medication, seminal plasma hormone, serum lipid levels and other indicators;At the same time, serum and seminal plasma samples of the two groups of patients before and after treatment were collected for bioinformatics analysis of protein spectrum to find the effector molecules of Gulingji capsule.

Detailed description

The WHO defines infertility as a condition in which a couple cohabitates and has normal sex, has not used contraception for more than a year and the woman has not been able to conceive naturally.Some male infertility patients who cannot find related infertility factors are called idiopathic male infertility.These male infertility patients are often characterized by abnormal sperm count (including oligospermia, azoospermia, occult sperm), abnormal motility (including asthenospermia, asthenospermia), or malformed sperm, collectively referred to as idiopathic oligospermia (idiopathic OAT). At present, the treatment methods of idiopathic OAT are mostly empirical treatment, including anti-oxidation treatment, treatment to improve cell energy metabolism, treatment to improve microcirculation of the whole body and reproductive system, etc.In general, traditional Chinese treatment should be combined with traditional Chinese medicine.However, the relevant mechanism of TCM treatment of OAT is not yet clear. The object of study for patients with idiopathic disease of OAT, the use of multicenter, randomized, double-blind, controlled, prospective clinical research, choose according to row, standard units of idiopathic male infertility clinics less weak abnormal sperm, randomly divided into experimental group and the placebo group, the comparison between the two groups of patients and semen parameters before and after medication, seminal plasma hormone, serum lipid levels and other indicators;At the same time, serum and seminal plasma samples of the two groups of patients before and after treatment were collected for bioinformatics analysis of protein spectrum to find the effector molecules of Gulingji capsule. It is assumed that the probable case loss rate in the trial is 20%, with 120 cases in each group, and a total of 240 cases are required. Drug treatment: Gulingji capsule was taken orally for 2 capsules, once before breakfast and dinner, and was taken with saline solution. The total treatment period was 90 days.(Placebo is rice flour)

Conditions

• Oligospermia

Interventions

Type	Name	Description
DRUG	Guilingji Capsule	This medicine is capsule medicine, take method is oral.
DRUG	Placebo	This medicine is capsule medicine（Placebo）, take method is oral.

Timeline

• Start date: 2021-12-06
• Primary completion: 2022-06-30
• Completion: 2022-12-31
• First posted: 2022-04-11
• Last updated: 2022-04-11

Locations

4 sites across 1 country: China