Protocol summary
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Study aim
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To assess the effect of tamsulosin versus pumpkin seed oil on clinical symptoms in patients with benign prostatic hyperplasia
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Design
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This is a single-blind randomized clinical trial, phase II, in which 80 eligible patients will be randomly assigned to the intervention and control groups
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Settings and conduct
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The eligible patients with benign prostatic hypertrophy referring to the Shahid Beheshti Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be single-blinded so that the physician examining the patients will be aware of the intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age of 50 to 90 years,
Benign prostatic hypertrophy
Exclusion criteria:
Indication of surgery,
Taking medications for the treatment of benign prostatic hypertrophy in the past 6 months
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Intervention groups
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Intervention group:
Pumpkin seed oil 360 mg (manufactured by Tehran Daru Pharmaceutical Co.) once every night for 3 months
Control group:
Tamsulosin capsule 0.4 mg (manufactured by Tasnim Pharmaceutical Co.) once every night for 3 months
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Main outcome variables
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Primary outcome:
Clinical symptoms, measuring prostate
General information
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Reason for update
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There has been a slight change in the intervention group that needs to be updated.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120215009014N340
Registration date:
2020-02-19, 1398/11/30
Registration timing:
retrospective
Last update:
2021-07-25, 1400/05/03
Update count:
1
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Registration date
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2020-02-19, 1398/11/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-08-23, 1398/06/01
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Expected recruitment end date
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2020-02-19, 1398/11/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of tamsulosin versus pumpkin seed oil on clinical symptoms in patients with benign prostatic hyperplasia: a single-blind randomized controlled trial
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Public title
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Effect of tamsulosin versus pumpkin seed oil on clinical symptoms in patients with benign prostatic hyperplasia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age of 50 to 90 years,
Benign prostatic hypertrophy
Exclusion criteria:
Indication of surgery,
Taking medications for treatment of benign prostatic hypertrophy in the past 6 months
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Age
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From 50 years old to 90 years old
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Gender
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Male
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Phase
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2
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Groups that have been masked
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- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "tamsulosin group" on one sheet and "pumpkin group" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as single-blind.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-08-10, 1398/05/19
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Ethics committee reference number
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IR.UMSHA.REC.1398.429
Health conditions studied
1
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Description of health condition studied
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Benign prostatic hypertrophy
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ICD-10 code
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D29.1
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ICD-10 code description
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Benign neoplasm of prostate
Primary outcomes
1
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Description
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Clinical symptoms
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Timepoint
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Before the intervention and then monthly for 3 months
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Method of measurement
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By taking history
2
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Description
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Measuring prostate
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Timepoint
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Before the intervention and 3 months later
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Method of measurement
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By sonography
Intervention groups
1
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Description
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Control group: Tamsulosin capsule 0.4 mg (manufactured by Tasnim Pharmaceutical Co.) once every night for 3 months
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Category
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Treatment - Drugs
2
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Description
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Control group: Tamsulosin capsule 0.4 mg (manufactured by Tasnim Pharmaceutical Co.) once every night for 3 months
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available