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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT2015011314333N27 |
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Date of registration:
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2015-01-31 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The effect of adding melatonin to tamsulosin to cure BPH
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Scientific title:
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The effect of adding or avoiding melatonin to tamsulosin to cure BPH |
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Date of first enrolment:
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2013-06-22 |
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Target sample size:
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108 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/13963 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
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Phase:
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N/A
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Dr. Bahram Samadzadeh
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Address:
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Emamreza hospital, Parastar boulevard
Kermanshah
Iran (Islamic Republic of) |
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Telephone:
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+98 83 3427 6309 |
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Email:
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bahram.samadzadeh@yahoo.com |
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Affiliation:
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Kermanshah University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion: male patients over 50 without urethral stricture; bladder cancer; prostate cancer; satisfaction; patients with urinary problems and IPSS =8.
Exclusion: patients with suspicious for malignancy; male patients over 90; patients with drug interactions with melatonin.
Exclusion criteria:
Age minimum:
50 years
Age maximum:
90 years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Hyperplasia of prostate
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BPH.
Hyperplasia of prostate
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Intervention(s)
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Intervention 1: Experiment group received 3 milligram melatonin in addition to traditional treatment. After a month, both groups were reanalyzed for IPSS criteria and the improvement of symptoms was evaluated. Intervention 2: The traditional treatment and 3 milligrams of placebo were prescribed for the control group. After a month, both groups were reanalyzed for IPSS criteria and the improvement of symptoms was evaluated.
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Experiment group received 3 milligram melatonin in addition to traditional treatment. After a month, both groups were reanalyzed for IPSS criteria and the improvement of symptoms was evaluated.
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Placebo
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The traditional treatment and 3 milligrams of placebo were prescribed for the control group. After a month, both groups were reanalyzed for IPSS criteria and the improvement of symptoms was evaluated.
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Treatment - Drugs
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Primary Outcome(s)
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IPSS criteria. Timepoint: Beginning to the study and a month after the study. Method of measurement: By doctor.
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Source(s) of Monetary Support
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Kermanshah University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Kermanshah University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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