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Comparative study on the effect of treatment of dietary regimens of Cotrimoxazole - Ciprofloxacin- Cefixime in the treatment of uncomplicated cystitis in females over 18 years of age

Protocol summary

Study aim
Determining the effect of cotrimoxazole, ciprofloxacin, cefixime in the treatment of uncomplicated cystitis in women over 18 years of age
Design
Clinical trial without control group, with parallel groups, without blinding, non-random, phase 2-3 on 150 patients
Settings and conduct
In this study, 150 women over the age of 18 with uncomplicated cystitis who Will refer to private health centers in Shahroud in 1399 are studied. Fifty people were treated with cotrimoxazole (400/160 twice a day) and Fifty people were treated with ciprofloxacin (500 mg twice daily) and Fifty people were treated with (400 mg once daily).At the same time as filling file and questionnaire, the first stage tests (U / A-U / C) are requested for the patient. and questionnaire , first stage tests (U/A - U/C) are requested for the patient. In the second visit (7-10 days later), the second stage tests are also requested. In the third stage, a month later, the patients who had a positive treatment response are evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Women over 18 with uncomplicated cystitis in Shahroud Exclusion criteria: Patients who cannot be accessed for any reason , have underlying and concomitant illnesses, take certain medications, people with anatomical disorders of the urinary tract, pregnant, lactating women
Intervention groups
1) First intervention group: 50 people treated with cotrimoxazole 400/160 twice a day 2) Second intervention group: 50 people treated with ciprofloxacin 500 mg, twice a day 3)Third Intervention group: 50 people treated with cefixime 400 mg , once a day
Main outcome variables
Symptoms of cystitis :ِ Dysuria , Frequency ,Suprapubic pain, Polyuria,Urgency

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200414047073N1
Registration date: 2020-10-17, 1399/07/26
Registration timing: registered_while_recruiting

Last update: 2020-10-17, 1399/07/26
Update count: 0
Registration date
2020-10-17, 1399/07/26
Registrant information
Name
Reihane Pishrouyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3377 1895
Email address
r.pishrouyan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study on the effect of treatment of dietary regimens of Cotrimoxazole - Ciprofloxacin- Cefixime in the treatment of uncomplicated cystitis in females over 18 years of age
Public title
Comparative study on the effect of treatment of dietary regimens of Cotrimoxazole - Ciprofloxacin - Cefixime in the treatment of uncomplicated cystitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women over 18 years old with uncomplicated cystitis living in Shahroud
Exclusion criteria:
Patients who cannot be accessed for any reason Patients with a history of underlying chronic disease Taking anticoagulants or continuous contraceptives People with anatomical disorders of the urinary tract Taking oral or injectable antibiotics prophylactically in the last 2 weeks Pregnant women lactating women Taking contraceptives Patients with concomitant diseases Patients with a positive history of kidney disease Diabetic patients history of seizure Patients with systemic infection Patients with flank pain Patients with signs of urinary tract infection more than 72 hours Resistance to all three drugs
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of shahroud Islamic Azad University Of medical Sciences
Street address
Shahroud Islamic Azad Univesity ,University Blvd,shahroud ,Semnan
City
shahroud
Province
Semnan
Postal code
43189-36199
Approval date
2019-07-08, 1398/04/17
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1398.037

Health conditions studied

1

Description of health condition studied
سیستیت بدون عارضه
ICD-10 code
N30
ICD-10 code description
Cystitis

Primary outcomes

1

Description
Urinary tract infection status
Timepoint
First visit, second visit (7 to 10 days later), third visit (one month later)
Method of measurement
U/A- U/C

2

Description
Symptoms of cystitis(ِDysuria،Frequency ،Suprapubic Tendernes،polyuria،Urgency)
Timepoint
First visit, second visit (7 to 10 days later), third visit (one month later)
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: 50 people treated with cotrimoxazole 400/160 twice a day
Category
Treatment - Drugs

2

Description
Second intervention group: 50 people treated with ciprofloxacin 500 mg twice daily
Category
Treatment - Drugs

3

Description
Third intervention group: 50 people treated with cefixime 400 mg once daily
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Beyki 's Private Office
Full name of responsible person
Reihane Pishrouyan
Street address
Unit 14, 3rd Floor,Bahar Doctors Building, 22 Bahman St., Shahroud
City
Shahroud
Province
Semnan
Postal code
3616615181
Phone
+98 23 3222 6830
Email
dr.beiky @gmail.com

2

Recruitment center
Name of recruitment center
Dr. Monire Amerian Private Office
Full name of responsible person
Reihane Pishrouyan
Street address
Central Doctors Building,22 Bahman St.,Shahroud
City
Shahroud
Province
Semnan
Postal code
3616615477
Phone
+98 23 3224 2777
Email
Amerian1060@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Reihane Pishrouyan
Street address
No. 11, Shahamat 9 Alley,South Miad St.,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3471646598
Phone
+98 28 3377 1895
Fax
+98 28 3378 7955
Email
r.pishrouyan@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Reihane pishrouyan
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Public Health
Street address
No. 11 ,9 Shahamat ,Alley South Miad St., Kowsar,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3471646598
Phone
+98 28 3377 1895
Fax
+98 28 3378 7955
Email
r.pishrouyan@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Reihane Pishrouyan
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 11 ,9 Shahamat ,Alley South Miad St., Kowsar,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3471646598
Phone
+98 28 3377 1895
Fax
+98 28 3378 7955
Email
R.pishrouyan@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Reihane pishrouyan
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 11 ,9 Shahamat ,Alley South Miad St., Kowsar,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3471646598
Phone
+98 28 3377 1895
Fax
+98 28 3378 7955
Email
r.pishrouyan@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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