Protocol summary

Summary
The aim of this study was to determine the effect of garlic tablets outcomes culture samples obtained from peripheral Catheters, is hospitalized patients. This clinical study was a Phase 3, double-blind, single center. 100 women condidate15-55 years with inclusion criteria: patients admitted to the intensive care unit Exclusion criteria: immunocompromised patients with AIDS or leukemia or decreased white blood cells; Receiving corticosteroids at high doses;Diabet; randomly selected, divide into two groups of 50people. The first group receive daily for 6 days and 1 tablet every 8 hours. The second group only receive routine care . checklist are checked after surgery. fever is responding to treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017041710222N9
Registration date: 2017-05-06, 1396/02/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-06, 1396/02/16
Registrant information
Name
Zahra Keivani
Name of organization / entity
Shahrekord University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 0016
Email address
keivani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Garlic Tablets outcomes culture samples obtained from peripheral catheters in ICU
Public title
Effects of Garlic Tablets outcomes culture samples obtained from peripheral Catheters
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients admitted to the intensive care unit Exclusion criteria: immunocompromised patients with AIDS or leukemia; decreased white blood cells; Receiving corticosteroids at high doses; Diabetes
Age
From 15 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double 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 Shahrekord University of Medical Sciences
Street address
shahrekord university of medical sciences, Kashani street, shahrekord
City
Shahrekord
Postal code
Approval date
2014-10-19, 1393/07/27
Ethics committee reference number
19-3-93

Health conditions studied

1

Description of health condition studied
catheter infection
ICD-10 code
T83.5
ICD-10 code description
Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system

Primary outcomes

1

Description
Fever
Timepoint
2 and 4 days after intervation
Method of measurement
Thermometer

Secondary outcomes

1

Description
Catheters Culture
Timepoint
2 and 4 days after intervation
Method of measurement
Bacterial culture

Intervention groups

1

Description
The first group receive daily for 6 days and 1 tablet every 8 hours
Category
Treatment - Drugs

2

Description
The second group receive routine care
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashani hospital in Shahrekord
Full name of responsible person
Hossein Madineh
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar street, shahrekord
City
shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Shahrekord University of Medical Science
Full name of responsible person
Dr. Kamal Solati
Street address
Kashani street, shahrekord university of medical sciences, shahrekord
City
Shahrekord
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 Shahrekord University of Medical Science
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
Hossein Madineh
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar street, shahrekord
City
Shahrekord
Postal code
Phone
00
Fax
Email
yadollahi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Hossein Madineh
Position
General Surgeon, Assistant Professor
Other areas of specialty/work
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar street, shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
yadollahi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University of Medical
Full name of responsible person
Hossein Madineh
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar street, shahrekord
City
Shahrekord
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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