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Control of chronic nonbacterial prostatitis symptoms

A clinical trial to comparison the effectiveness of melatonin and capsules containing starch (placebo) as an adjuvant therapy to control symptoms of chronic nonbacterial prostatitis patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016071025507N4
Enrollment
116
Registered
2016-07-19
Start date
2016-08-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic nonbacterial prostatitis. Chronic prostatitis

Interventions

Intervention 1: Control group: patients in this group will receive 2mg of terazosin tablets (Razak Company) plus 3mg of starch capsules (placebo). Intervention 2: Intervention group: patients in this
Treatment - Drugs
Control group: patients in this group will receive 2mg of terazosin tablets (Razak Company) plus 3mg of starch capsules (placebo).
Intervention group: patients in this group will receive 3mg of melatonin capsules daily for six weeks.

Sponsors

Vice Chancellor for Research of Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 139 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age over 18 years; no prior history of other urinary system disorders such as urinary tract stones, neurogenic bladder, and urinary infections; no history of underlying diseases such as cirrhosis, renal failure, diabetes, or hypertension; normal levels of urine, fasting blood sugar (FBS), and creatinine; normal results on the first neurological examination of the perineal area, lower limbs, lower limb reflexes, and bulbocavernosus reflex; having weight between 50 to 100 kg; no use of other medicines; no signs of psychological disorders; confirmed diagnosis of chronic prostatitis; creatinine equal to or lower than 1.2 mg; platelet count over 100000/mm3; non-sensitivity to anti-epileptic drugs, pregabalin, thiazolidinediones, or other anti-diabetic agents. Exclusion criteria: Unwillingness to continue the study; major side-effects due to the use of medications.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain scale. Timepoint: Two, four and six weeks after intervention. Method of measurement: NIH-CPSI and GRA questionnaire.

Secondary

MeasureTime frame
Side-effects of pharmaceuticals including nausea, vomiting, hypotension, itching and drowsiness. Timepoint: Two, four and six weeks after intervention. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Sirous

Arak University of Medical Sciences

m-jiriaie@mscstu.scu.ac.ir+98 86 3313 6058

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026