Protocol summary
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Study aim
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Comparison of ciprofloxacin and compound of ciprofloxacin and propolis therapy on women with sistit
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Design
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The present study is a seven-day intervention with propolis or placebo extract in women with cystitis. Written consent will be obtained from the patients participating in the study at the time of registration. Eligibility will be evaluated for the inclusion criteria first. The patients were allocated to either an intervention or placebo group by block randomization. The sample size will be 60 for each group. Qualified participants are randomly assigned to one of two groups. Participants will be blind in the study. Before and after the intervention. clinical symptoms and laboratory tests will be measured.
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Settings and conduct
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Qom University of Medical Sciences, Kamkaran Arab Nia Hospital
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Participants/Inclusion and exclusion criteria
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Women with UTI; lower urinary tract infection for the first time; no chronic disease
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Intervention groups
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Intervention group: Propolis extract at a dose of 500 mg twice daily for seven consecutive days and 250 mg ciprofloxacin twice daily
Control group: placebo at a dose of 500 mg twice daily for seven consecutive days and 250 mg ciprofloxacin twice daily
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Main outcome variables
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Bacteria count, Red blood cell in urine, clinical symptoms including hematuria, urinary frequency, dysuria, suprapubic pain, and urgency, ESR, CRP
General information
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Reason for update
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اصلاح بعضی قسمت های مطالعه ( تعداد کل شرکت کنندگان مطالعه و روش تصادفی سازی) که در نسخه ی اول اشتباه تایپ شده بود
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180721040552N1
Registration date:
2019-04-04, 1398/01/15
Registration timing:
registered_while_recruiting
Last update:
2023-01-25, 1401/11/05
Update count:
1
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Registration date
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2019-04-04, 1398/01/15
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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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2019-03-17, 1397/12/26
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Expected recruitment end date
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2019-05-16, 1398/02/26
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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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Comparison of the therapeutic effect of ciprofloxacin and Combination of ciprofloxacin and propolis on women with cystitis
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Public title
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Comparison of the therapeutic effect of ciprofloxacin and Combination of ciprofloxacin and propolis on women with cystitis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women with UTI (cystitis)
Age between 18 and 60 years
lower urinary tract infection for the first time
Exclusion criteria:
Alcohol use
Chronic disease
Taking antibiotics and other drugs
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Age
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From 18 years old to 60 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The patients were allocated to either an intervention or placebo group by block randomization.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Propolis capsules and placebo capsules were completely identical in packages and were coded by the researcher so that the studied subjects did not know the type of package contents.
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Placebo
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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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2019-03-04, 1397/12/13
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Ethics committee reference number
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ir.muq.rec.1397.200
Health conditions studied
1
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Description of health condition studied
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Cystitis
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ICD-10 code
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N30.8
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ICD-10 code description
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Other cystitis
Primary outcomes
1
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Description
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Urinary bacteria
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Timepoint
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At the beginning of the study and 7 days after the start of the study
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Method of measurement
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Urine culture
Secondary outcomes
1
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Description
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White blood cells
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Timepoint
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At the beginning of the study and 7 days after the start of the study
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Method of measurement
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Blood test
2
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Description
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Clinical symptoms
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Timepoint
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At the beginning of the study and 7 days after the start of the study
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention group: Every 12 hours, a supplement of 500 mg propolis and one 250 mg ciprofloxacin control
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Category
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Treatment - Other
2
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Description
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Control group: Placebo and ciprofloxacin 250 mg every 12 hours
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Category
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Placebo
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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Ghoum 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Information on the main outcome of the study
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When the data will become available and for how long
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After printing the article
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To whom data/document is available
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All people
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Under which criteria data/document could be used
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To conduct scientific studies
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From where data/document is obtainable
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Personal email
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What processes are involved for a request to access data/document
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Send mail
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Comments
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