Comparison of ciprofloxacin and compound of ciprofloxacin and propolis therapy on women with sistit
Design
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 at first. The randomization will be performed using the classified block method. The sample size will be 95 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.
Settings and conduct
Qom University of Medical Sciences, Kamkaran Arab Nia Hospital
Participants/Inclusion and exclusion criteria
Women with UTI; lower urinary tract infection for the first time; no chronic disease
Intervention groups
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
Main outcome variables
Bacteria count, White blood cell, Red blood cell in urine, Frequency, ESR, CRP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180721040552N1
Registration date:2019-04-04, 1398/01/15
Registration timing:registered_while_recruiting
Last update:2019-04-04, 1398/01/15
Update count:1
Registration date
2019-04-04, 1398/01/15
Registrant information
Name
Mehdi Shekari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3883 6354
Email address
mehdishekari025@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-17, 1397/12/26
Expected recruitment end date
2019-05-16, 1398/02/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effect of ciprofloxacin and Combination of ciprofloxacin and propolis on women with cystitis
Public title
Comparison of the therapeutic effect of ciprofloxacin and Combination of ciprofloxacin and propolis on women with cystitis
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
190
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qom University of Medical Sciences
Street address
shahid lavasani ave
City
qom
Province
Ghoum
Postal code
3713649373
Approval date
2019-03-04, 1397/12/13
Ethics committee reference number
ir.muq.rec.1397.200
Health conditions studied
1
Description of health condition studied
Cystitis
ICD-10 code
N30.8
ICD-10 code description
Other cystitis
Primary outcomes
1
Description
Urinary bacteria
Timepoint
At the beginning of the study and 7 days after the start of the study
Method of measurement
Urine culture
Secondary outcomes
1
Description
White blood cells
Timepoint
At the beginning of the study and 7 days after the start of the study
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: Every 12 hours, a supplement of 500 mg propolis and one 250 mg ciprofloxacin control
Category
Treatment - Other
2
Description
Control group: Placebo and ciprofloxacin 250 mg every 12 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان کامکار عرب نیا
Full name of responsible person
dr mohammad heydari
Street address
19 dey ave
City
qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3771 3511
Email
kamkar@muq.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
mehdi shekari
Street address
shahid lavasani ave
City
qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3107 1320
Email
pajoohesh-pezeshki@muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mehdi Shekari
Position
Master of Science In Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No 1 Alley .Safashahr Ave. Alghadir blvd
City
Qom
Province
Ghoum
Postal code
3717745859
Phone
+98 25 3883 6354
Email
Mehdishekari025@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mehdi Shekari
Position
Master of Science In Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No 1 Alley .Safashahr Ave. Alghadir blvd
City
Qom
Province
Ghoum
Postal code
3717745859
Phone
+98 25 3883 6354
Email
Mehdishekari025@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mehdi Shekari
Position
Master of Science In Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No 1 Alley .Safashahr Ave. Alghadir blvd
City
Qom
Province
Ghoum
Postal code
3717745859
Phone
+98 25 3883 6354
Email
Mehdishekari025@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information on the main outcome of the study
When the data will become available and for how long
After printing the article
To whom data/document is available
All people
Under which criteria data/document could be used
To conduct scientific studies
From where data/document is obtainable
Personal email or google
What processes are involved for a request to access data/document