Ignite Creation Date:
2024-05-06 @ 5:38 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05378646
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2022-04-20
Brief Title:
Efficiency and Safety of the Drug Ingaron Interferon-gamma Human Recombinant in the Treatment of Chronic Prostatitis
Sponsor:
SPP Pharmaclon Ltd
Organization:
SPP Pharmaclon Ltd
Study Overview
Official Title:
An Open Controlled Study of the Efficacy and Safety of Ingaron Interferon-gamma Human Recombinant in the Treatment of Chronic Prostatitis
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
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:
ING-HP-1
Brief Summary:
The primary purposes of the study are to evaluate the effectiveness of Ingaron in the complex therapy of chronic prostatitis to assess the safety of using Ingaron in patients with chronic prostatitis
Detailed Description:
Literature data and the results of preclinical studies of interferon-gamma as well as the features of the immunopathogenesis of chronic prostatitis show the expediency of studying the use of Ingaron in this pathology
The study was conducted to compare the efficacy and safety of Ingaron in combination with standard therapy with its subcutaneous administration and standard therapy in patients with chronic prostatitis
The study was planned to include 50 male patients aged at least 18 years with a confirmed diagnosis of chronic prostatitis
In the course of the study Ingaron was administered at a dose of 500000 IU once a day every other day In addition to Ingaron patients received antibiotic therapy anti-inflammatory drugs alpha-blockers if necessary Magnetic laser therapy and prostate massage were also provided
The patients were divided into 2 groups main and control
The study was conducted to compare the efficacy and safety of Ingaron in combination with standard therapy with its subcutaneous administration and standard therapy in patients with chronic prostatitis
The study was planned to include 50 male patients aged at least 18 years with a confirmed diagnosis of chronic prostatitis
In the course of the study Ingaron was administered at a dose of 500000 IU once a day every other day In addition to Ingaron patients received antibiotic therapy anti-inflammatory drugs alpha-blockers if necessary Magnetic laser therapy and prostate massage were also provided
The patients were divided into 2 groups main and control
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