Chronic prostatitis. Chronic prostatitis
Conditions
Interventions
Intervention 1: Intervention group: Take 5 mg of oral melatonin (tablet) once daily, at night before bed, for 12 weeks. Intervention 2: Control group: Receiving a placebo with a shape and color simila
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Males aged 18 to 65 years. Definite diagnosis of CP/CPPS type IIIA or IIIB according to NIH criteria Presence of symptoms for at least 3 months in the last 6 months NIH-CPSI score = 15 Written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Active urinary tract infection or acute fever. Ureteral or bladder stones or prostate malignancy. Use of antibiotics or anti-inflammatory drugs within the past 4 weeks. History of prostate surgery or prostate cancer. Severe psychiatric illness or untreated sleep disorders Known sensitivity to melatonin or its components. Non-cooperation or withdrawal of the volunteer during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total score of the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) questionnaire. Timepoint: Questionnaire scores at the beginning of the study and at weeks 6, 12, and 24 after melatonin administration. Method of measurement: National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum level of Interleukin 6. Timepoint: Interleukin 6 measurements at the beginning of the study and at weeks 6 and 12 after melatonin administration. Method of measurement: Measurement of serum interleukin 6 levels using the ELISA method.;Serum level of Tumor Necrosis Factor. Timepoint: Tumor Necrosis Factor measurements at the beginning of the study and at weeks 6 and 12 after melatonin administration. Method of measurement: Measurement of serum Tumor Necrosis Factor levels using the ELISA method.;Serum level of Interleukin-1 beta. Timepoint: Interleukin-1 beta measurements at the beginning of the study and at weeks 6 and 12 after melatonin administration. Method of measurement: Measurement of serum interleukin-1 beta levels using the ELISA method.;Serum level of Malondialdehyde. Timepoint: Malondialdehyde measurements at the beginning of the study and at weeks 6 and 12 after melatonin administration. Method of measurement: Measurement of serum Malondialdehyde levels using the ELISA method.;Serum level of C-Reactive Protein (CRP). Timepoint: C-Reactive Protein measurements at the beginning of the study and at weeks 6 and 12 after melatonin administration. Method of measurement: Measurement of serum C-reactive protein levels using the ELISA method.;Pittsburgh Sleep Quality Index (PSQI) score. Timepoint: Completion of the Pittsburgh Sleep Quality Index (PSQI) questionnaire at the beginning of the study and at weeks 6, 12, and 24 after melatonin administration. Method of measurement: Pittsburgh Sleep Quality Index (PSQI) questionnaire.;Hospital Anxiety and Depression Scale (HADS) score. Timepoint: Completion of the Hospital Anxiety and Depression Scale (HADS) questionnaire at the beginning of the study and at weeks 6, 12, and 24 after melatonin administration. Method of measurement: Hospital Anxiety and Depression Scale (HADS) questionnaire.;International Index of Erectile Function (IIEF-5) score. Timepoint: Completion of the International Index of Erectile Funct | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSeyyed Ali Hojjati
Shahid Beheshti University of Medical Sciences
Outcome results
None listed