Urinary tract infections (UTIs) are the most common medical complication experienced by individuals living with spinal cord lesion. . To day cranberry is thought to improve urinary tract health . This study design to compaire efficacy of cranberry juice on bacteriuria and pyuria in spinal cord lesion patients .
60 patients with spinal cord lesion will selected and will divided two groups in this randomized, double blind, placebo controlled clinical trial.We obtained informed written consent from eligible patients.Data will collected by checklist and questionnaire . The case patients will given a dose of 250 ml of cranberry juice cocktail with 30% concentration, daily with meals. . The control group will fed the same amount of a placebo cocktail. Urine analysis and culture will carried out and will compaired beror intervention and two weeks after interventions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112073912N4
Registration date:2012-06-18, 1391/03/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-06-18, 1391/03/29
Registrant information
Name
Kobra Nourian
Name of organization / entity
Sharekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5648
Email address
noorian@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2012-12-01, 1391/09/11
Expected recruitment end date
2013-12-02, 1392/09/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of cranberry juice on bacteriuria and puria in spinal cord lesion.
Public title
Evaluation of cranberry juice on bacteriuria and puria in spinal cord lesion.
Purpose
Prevention
Inclusion/Exclusion criteria
Exclusion criteria:
Patients with definite indications for antibiotic treatment (pyocystitis, symptomatic UTI, fever, flank tenderness);Patients with creatinine levels greater than 1.5 gr/dl;Patients with gastrointestinal intolerance or those with allergy to cranberries;Patients who did not complete the clinical trial.
inclusion criteria:patients with spinal cord injery , age between 19-60 y;patients (51 male and 9 female) with creatinine levels below 1.5 mg/dl and in the analysis of their urine white blood cell (WBC) counts were greater than 10 in a high-powered field (pyuria) or with a presence of bacteriuria (>= 104 cc/ml) in their urine culture
Age
From 19 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Kashani Hospital
City
Shahrekord
Postal code
8814819877
Approval date
2011-07-27, 1390/05/05
Ethics committee reference number
860
Health conditions studied
1
Description of health condition studied
Spinal Cord Lesion
ICD-10 code
S30-S39
ICD-10 code description
Injury of spinal cord, level unspecified
Primary outcomes
1
Description
colony count
Timepoint
Before and 2 weeks after ntervention
Method of measurement
paraclinic
Secondary outcomes
1
Description
odor of urine
Timepoint
before and 2weeks after intervention
Method of measurement
paraclinic
2
Description
PH OF urine
Timepoint
before and 2weeks after intervention
Method of measurement
paraclinic
3
Description
Type of microorganism
Timepoint
before and 2weeks after intervention
Method of measurement
paraclinic
Intervention groups
1
Description
Case: 250cc cranberry juice placebo daily with meals for 2 weeks.
Category
Prevention
2
Description
Control : 250cc placebo daily with meals for 2 weeks.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital.
Full name of responsible person
Street address
Kashani Hospital-Parastar St
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Shahrekord University of Medical Sciences-Vice chancelly for Research
Street address
Vice chancelly for Research-Kashani St
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord University of Medical Sciences
Full name of responsible person
Kobra Noorian
Position
Lecturer
Other areas of specialty/work
Street address
Nursing Faculity
City
Shahrekord
Postal code
Phone
+98 38 1333 5648
Fax
Email
noorian@skums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Mohammad Rajaei
Position
Assistant proffesor
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 1226 4826
Fax
Email
noorian@skums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Kobra Noorian
Position
Lecturer
Other areas of specialty/work
Street address
Nursing Department of Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
8814819877
Phone
+98 38 1333 5648
Fax
Email
noorian@skums.ac.ircobranori@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)