The effect of green tea on treatment of uncomplicated urinary tract infection
The aim of this study is to evaluate the effect of green tea on treatment of uncomplicated urinary tract infection. This study is a randomized double blind clinical trial is performed on 90 patients. the inclusion criteria are women with uncomplicated urinary tract infection that recieve cotrimaxazole concurrently and 18 to 50 years old. The exclusion criteria are pregnancy, HIV infection, diabetes and other infections. Patients divide in intervention and control group. Both of groups receive co-trimaxazole 480 mg twice daily for 3 days. In intervention group, participants receive green tea as one capsule, daily for three days. In control group one capsule of starch is given daily for three days. The urine culture and analysis is done on day 0 and 4. Patients complete a questionnaire about their urinary symptoms such as dysuria, frequent urination, suprapubic pain, and hematuria every day during this 3 days period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506156026N3
Registration date:2015-07-07, 1394/04/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-07-07, 1394/04/16
Registrant information
Name
Fatemeh Dabaghzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5034
Email address
dabaghzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iranian national elites' organization
Expected recruitment start date
2015-11-06, 1394/08/15
Expected recruitment end date
2016-11-05, 1395/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of green tea on treatment of uncomplicated urinary tract infection
Public title
A clinical trial to evaluate the effect of green tea in comparison with placebo on treatment of uncomplicated urinary tract infection in women by using urine culture and symptoms of disease
Purpose
Treatment
Inclusion/Exclusion criteria
Iclusion criteria:
age 18- 55 years old; women with uncomplicated urinary tract infection that recieve cotrimaxazole concurrently
Exclusion Criteria:
Pregnancy; HIV positive; Diabetes; Other infections
Age
From 18 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Keram University of Medical Sciences
Street address
Ethics committee of Keram University of Medical Sciences, Tahmasb abad Ave, Kerman, Iran
City
Kerman
Postal code
Approval date
2014-12-08, 1393/09/17
Ethics committee reference number
92/627/کا
Health conditions studied
1
Description of health condition studied
Acute cystitis
ICD-10 code
N30.0
ICD-10 code description
Acute cystitis
Primary outcomes
1
Description
Urinary tract infection symtoms such as dysuria, frequent urination, suprapubic pain, and hematuria
Timepoint
Daily for three days
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Urine culture
Timepoint
Day 0 and 4
Method of measurement
Cultured pathogen
Intervention groups
1
Description
In intervention group, participants receive green tea as one capsule daily for three days. They receive co-trimaxazole 480 mg twice daily for 3 days concurrently. Each capsule contains the freeze dried extract of iranian green tea. That equates to approximately 150 mg of EGC per capsule. HPLC is used to determine the amount of EGC per gram of green tea.
Category
Treatment - Drugs
2
Description
In control group one capsule of starch is given daily for three days.
They receive co-trimaxazole 480 mg twice daily for 3 days concurrently.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat clinic
Full name of responsible person
Farhad Sarafzadeh
Street address
Besat clinic, Tahmasb abad Ave, Kerman, Iran
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Kerman University of Medical Sciences
Full name of responsible person
Miz. Hasani
Street address
Vice Chancellor for research of Kerman University of Medical Sciences, Tahmasb abad Ave, Kerman, Iran
City
Kerman
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman university of medical sciences
Full name of responsible person
Fatemeh Dabaghzadeh
Position
Clinical Pharmacist
Other areas of specialty/work
Street address
Haft-Bagh High-Way, Faculty of Pharmacy, Kerman University of Medical, Kerman, Iran
City
Kerman
Postal code
76169-13555
Phone
+98 34 3132 5212
Fax
+98 34 3132 5003
Email
fatemeh_dabaghzadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman university of medical sciences
Full name of responsible person
Fatemeh Dabaghzadeh
Position
clinical pharmacist
Other areas of specialty/work
Street address
Haft-Bagh High-Way, Faculty of Pharmacy, Kerman University of Medical, Kerman, Iran
City
Kerman
Postal code
76169-13555
Phone
+98 34 3132 5212
Fax
+98 34 3132 5003
Email
fatemeh_dabaghzadeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman university of medical sciences
Full name of responsible person
Fatemeh Dabaghzadeh
Position
Clinical Pharmacist
Other areas of specialty/work
Street address
Haft-Bagh High-Way, Faculty of Pharmacy, Kerman University of Medical, Kerman, Iran
City
Kerman
Postal code
76169-13555
Phone
+98 34 3132 5212
Fax
+98 34 3132 5003
Email
fatemeh_dabaghzadeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)