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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.
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 500,000 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Patients received Ingaron 500,000 IU subcutaneously once a day, every other day. The course of treatment is 7 injections. The first injection was given on the first day of active therapy. Subsequent injections were given every other day. The period of active therapy was 14 days. |
|
| Control | No Intervention | Patients received standard treatment for chronic prostatitis. The period of active therapy was 14 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon gamma human recombinant (IFN-G) | Drug | received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dynamics of the total score and improvement in the quality of life on the scale IPSS. | The sum of points was assessed, as well as the symptom complex on the basis of the "IPSS" questionnaire - the international system for the total assessment of symptoms of prostate diseases in points (WHO, 1992). The severity of symptoms was assessed from 0 to 6 points. symptoms of prostate diseases in points (WHO, 1992). The severity of symptoms is rated from 0 to 6 points. | Day 13 |
| Immunohistochemical study of prostate secretion with assessment of cytological parameters. | Content of polymorphonuclear leukocytes in prostate secretion. | Day 14 |
| Immunohistochemical study of prostate secretion with assessment of cytological parameters. | The content of lymphocytes in prostate secretion. | Day 14 |
| Evaluation of cytological parameters of prostate secretion. | The number of lecithin grains. | Day 14 |
| Evaluation of cytological parameters of prostate secretion. | The number of epithelial cells. | Day 14 |
| Microscopy of prostate secretion and immunohistochemical study of prostate secretion with assessment of cytological parameters. | The effect of interferon-gamma on T-lymphocytes. | Day 14 |
| Evaluation of cytological parameters of prostate secretion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonid Apanansky, Master | SPP Pharmaclon Ltd. | Study Director |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 13, 2025 | |
| Reset | Feb 5, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 13, 2025 | Feb 5, 2025 |
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The content of polymorphonuclear leukocytes in prostate secretion.
| Day 90 |
| Immunohistochemical study of prostate secretion with assessment of cytological parameters. | The content of lymphocytes in prostate secretion. | Day 90 |
| Evaluation of cytological parameters of prostate secretion. | The number of lecithin grains. | Day 90 |
| Evaluation of cytological parameters of prostate secretion. | The number of epithelial cells. | Day 90 |
| Microscopy of prostate secretion and immunohistochemical study of prostate secretion with assessment of cytological parameters. | The effect of interferon-gamma on T-lymphocytes. | Day 90 |
| Evaluation of indicators of urination. Ultrasound of the prostate gland. | Ultrasound of the prostate gland. | Day 90 |
| Evaluation of indicators of urination. Urofluometry. | Urofluometry. | Day 90 |
| Evaluation of indicators of urination. General urine analysis. | General urine analysis. | Day 90 |
| Evaluation of the inter-relapse period. Identification of an exacerbation of a chronic process. | Percentage of patients with exacerbation of chronic prostatitis and signs of disease recurrence during the follow-up period. | Month 3 |
| Evaluation of the inter-relapse period. Identification of signs of a relapse of the disease. | Percentage of patients with exacerbation of chronic prostatitis and signs of disease recurrence during the follow-up period. | Month 3 |
| Evaluation of the inter-relapse period. Identification of an exacerbation of a chronic process. | Percentage of patients with exacerbation of chronic prostatitis and signs of disease recurrence during the follow-up period. | Month 6 |
| Evaluation of the inter-relapse period. Identification of signs of a relapse of the disease. | Percentage of patients with exacerbation of chronic prostatitis and signs of disease recurrence during the follow-up period. | Month 6 |