Ignite Creation Date:
2024-05-06 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05320536
Status:
UNKNOWN
Last Update Posted:
2022-04-11
First Post:
2021-12-23
Brief Title:
A Clinical Study of Gulingji Capsule in the Treatment of Idiopathic Oligospermia Asthenia and Teratozoospermia
Sponsor:
Jinling Hospital China
Organization:
Jinling Hospital China
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Multicenter Clinical Study of Gulingji Capsule in the Treatment of Idiopathic Oligospermia Asthenia and Teratozoospermia
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 indicatorsAt 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 naturallySome male infertility patients who cannot find related infertility factors are called idiopathic male infertilityThese 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 etcIn general traditional Chinese treatment should be combined with traditional Chinese medicineHowever 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 indicatorsAt 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 daysPlacebo is rice flour
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 etcIn general traditional Chinese treatment should be combined with traditional Chinese medicineHowever 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 indicatorsAt 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 daysPlacebo is rice flour
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None