A Phase 4 interventional study of Guilingji Capsule and Placebo in Oligospermia, sponsored by Jinling Hospital, China. Status unknown at 4 sites in China. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-04-11.
Sponsored by Jinling Hospital, China · Phase 4, Interventional, and Treatment
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.
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)
Exclusion Criteria:
Guilingji capsule Take 2 tablets orally, once before breakfast and dinner, and take them with saline. The total treatment period is 90 days.
Drug: Guilingji Capsule
Placebo Take 2 tablets orally, once before breakfast and dinner, and take them with saline. The total treatment period is 90 days
Drug: Placebo
This medicine is capsule medicine, take method is oral.
This medicine is capsule medicine（Placebo）, take method is oral.
TNPMS
Total sperm count in forward motion
Time frame: 1 years
DFI
Sperm DNA fragmentation rate
Time frame: 1 years
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Jinling Hospital, China