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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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History
# Registration date Revision Id
2 2021-08-09, 1400/05/18 253775
1 2019-04-04, 1398/01/15 85152
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  • Protocol summary

    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.
    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.
    مطالعه حاضر یک مداخله هفت روزه با عصاره پروپولیس یا پلاسبو در زنان مبتلا به سیستیت خواهد بود. رضایت آگاهانه نوشته شده از بیماران شرکت کننده در مطالعه در زمان ثبت نام بدست خواهد آمد.شرکت کنندگان در اولین دیدار برای معیارهای شایستگی برای حضور در مطالعه ارزیابی خواهند شد. روش تصادفی با استفاده از روش بلوک طبقه بندی شده انجام خواهد شد.حجم نمونه برای هر گروه 95 نفر خواهد بود. شرکت کنندگان واجد شرایط به طور تصادفی به یکی از دو گروه مطالعه اختصاص داده می شوند. شرکت کنندگان در مطالعه کور خواهند شد. قبل و بعد از مداخله علایم بالینی و ازمایشگاهی اندازه گیری و ثبت می شود.
    مطالعه حاضر یک مداخله هفت روزه با عصاره پروپولیس یا پلاسبو در زنان مبتلا به سیستیت خواهد بود. رضایت آگاهانه نوشته شده از بیماران شرکت کننده در مطالعه در زمان ثبت نام بدست خواهد آمد.شرکت کنندگان در اولین دیدار برای معیارهای شایستگی برای حضور در مطالعه ارزیابی خواهند شد. بیماران به صورت تصادفی به دو گروه مداخله یا دارونما تقسیم شدند.حجم نمونه برای هر گروه 60 نفر خواهد بود. شرکت کنندگان واجد شرایط به طور تصادفی به یکی از دو گروه مطالعه اختصاص داده می شوند. شرکت کنندگان در مطالعه کور خواهند شد. قبل و بعد از مداخله علایم بالینی و ازمایشگاهی اندازه گیری و ثبت می شود.
    Bacteria count, White blood cell, Red blood cell in urine, Frequency, ESR, CRP
    Bacteria count, Red blood cell in urine, clinical symptoms including hematuria, urinary frequency, dysuria, suprapubic pain, and urgency, ESR, CRP
    باکتری -esr-crp-گلبولهای سفید خون-سوزش ادرار-تکرر ادرار
    تعداد باکتری، گلبول قرمز در ادرار، علائم بالینی شامل هماچوری، تکرر ادرار، سوزش ادرار، درد فوق عانه و فوریت، ESR، CRP

  • General information

    Not randomized
    Randomized
    190
    120
    empty
    اصلاح بعضی قسمت های مطالعه ( تعداد کل شرکت کنندگان مطالعه و روش تصادفی سازی) که در نسخه ی اول اشتباه تایپ شده بود
    empty
    Correcting some parts of the study (total number of study participants and randomization method) that were typed incorrectly in the first version
    The patients were allocated to either an intervention or placebo group by block randomization.
    بیماران به صورت تصادفی به دو گروه مداخله یا دارونما تقسیم شدند.

  • Secondary outcomes

    #1
    empty
    Clinical symptoms
    empty
    علائم بالینی
    empty
    At the beginning of the study and 7 days after the start of the study
    empty
    ابتدای مطالعه و 7 روز بعد از شروع مطالعه
    empty
    Questionnaire
    empty
    پرسشنامه

  • Intervention groups

    #1
    Treatment - Drugs
    Placebo

  • Recruitment centers

    #1
    Name of recruitment center - English: بیمارستان کامکار عرب نیا
    Name of recruitment center - Persian: Kamkaran Arab Nia Hospital
    Full name of responsible person - English: dr mohammad heydari
    Full name of responsible person - Persian: دکتر محمد حیدری
    Street address - English: 19 dey ave
    Street address - Persian: خیابان 19 دی
    City - English: qom
    City - Persian: قم
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3713649373
    Phone: +98 25 3771 3511
    Fax:
    Email: kamkar@muq.ac.ir
    Web page address:
    Name of recruitment center - English: Kamkaran Arab Nia hospital
    Name of recruitment center - Persian: بیمارستان کامکار عرب نیا
    Full name of responsible person - English: Dr Mohammad Heydari
    Full name of responsible person - Persian: دکتر محمد حیدری
    Street address - English: 19Dey Ave
    Street address - Persian: خیابان 19 دی
    City - English: Qom
    City - Persian: قم
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3713649373
    Phone: +98 25 3771 3511
    Fax:
    Email: kamkar@muq.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: mehdi shekari
    Full name of responsible person - Persian: مهدی شکاری
    Street address - English: shahid lavasani ave
    Street address - Persian: خیابان شهید لواسانی
    City - English: qom
    City - Persian: قم
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3713649373
    Phone: +98 25 3107 1320
    Fax:
    Email: pajoohesh-pezeshki@muq.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mehdi Shekari
    Full name of responsible person - Persian: مهدی شکاری
    Street address - English: Shahid Lavasani Ave
    Street address - Persian: خیابان شهید لواسانی
    City - English: Qom
    City - Persian: قم
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3713649373
    Phone: +98 25 3107 1320
    Fax:
    Email: pajoohesh-pezeshki@muq.ac.ir
    Web page address:

  • Sharing plan

    Personal email or google
    Personal email
    ایمیل شخصی و یا گوگل
    ایمیل شخصی

Protocol summary

Study aim
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 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.
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, Red blood cell in urine, clinical symptoms including hematuria, urinary frequency, dysuria, suprapubic pain, and urgency, ESR, CRP

General information

Reason for update
اصلاح بعضی قسمت های مطالعه ( تعداد کل شرکت کنندگان مطالعه و روش تصادفی سازی) که در نسخه ی اول اشتباه تایپ شده بود
Acronym
IRCT registration information
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
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: 120
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were allocated to either an intervention or placebo group by block randomization.
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

2

Description
Clinical symptoms
Timepoint
At the beginning of the study and 7 days after the start of the study
Method of measurement
Questionnaire

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
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Kamkaran Arab Nia hospital
Full name of responsible person
Dr Mohammad Heydari
Street address
19Dey 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
What processes are involved for a request to access data/document
Send mail
Comments
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