The aims of this study is comparison the effect of Echinacea and chlorhexidine mouthwash on microbial flora of oral cavity. In this study 70 intubated patients who admitted in ICU ward of Vali Asr Hospital, will be randomly divided into two groups.Technique, timing and frequency of mouthwash application is similar in both groups. patients with age of 18-65 years old who were admitted in ICU Less than 12 hours will eligible to the study. Transferring from ICU or death before the completion of intervention; allergy to herbal medications; history or current chronic or immune system diseases are exclusion criteria. culture of oral specimens will taken at 0, 4 days after intervention. oral hygiene check lists including BOAS and MPS will be completed at 0 and 4 days after intervention too.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012092610942N1
Registration date:2012-11-05, 1391/08/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-05, 1391/08/15
Registrant information
Name
Mahdi Safarabadi
Name of organization / entity
Arak University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1226 8316
Email address
safarabadi.m@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Arak University of Medical Siences.
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of echinacea and chlorhexidine mouthwashes on oral health of intubated patients in the Intensive Care Unit
Public title
Comparison of the effect of echinacea and chlorhexidine mouthwashes on oral health of intubated patients in the Intensive Care Unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :
endotracheal intubation; 18-65 years of old, admission inICU less than 12 hours.
Exclusion criteria :
transfering from ICU or death before the completion of intervention; any physical damage caused by the endotracheal intubation or airway or any other physical factors; Artificial teeth; antibiotic consumption before ICU admission; history of admission in other hospital wards befor ICU admission; pregnancy; allergy to herbal medications;history or current choronic or immune system diseases.
Age
From 18 years old to 65 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Arak University of Medical Sciences
Street address
Arak.Arak university of medical sciences.
City
Arak
Postal code
Approval date
2012-05-16, 1391/02/27
Ethics committee reference number
91-126-5
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases
2
Description of health condition studied
Diseases of pulp and periapical tissues
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
3
Description of health condition studied
Other disorders of teeth and supporting structures
ICD-10 code
K08
ICD-10 code description
Other disorders of teeth and supporting structures
Primary outcomes
1
Description
Oral microbial flora
Timepoint
Day 0,4
Method of measurement
culture of oral specimens
2
Description
oral health
Timepoint
Day 0,4
Method of measurement
BOAS and MPS check lists
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Echinacea 2% mouthwash, 3 times / day for 4 days. using by Applicator Swab for 10 min each time.
Category
Treatment - Drugs
2
Description
control group: chlorhexidine 2% mouthwash, 3 times/ day for 4 days, using by Applicator Swab for 10 min each time.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital of Arak city
Full name of responsible person
Mahdi Safarabadi
Street address
Valiasr hospital, Valiasr street, Arak.
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Arak University of Medical Sciences
Full name of responsible person
Dr. Davod Hekmatpuo
Street address
Arak University of Medical Sciences, Arak.
City
Arak
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 Arak 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
Arak University of Medical Sciences.
Full name of responsible person
Mahdi safarabadi
Position
Student of MA Nursing Special.
Other areas of specialty/work
Street address
Vali Asr hospital, Arak University of Medical Sciences, Arak.
City
Arak
Postal code
Phone
+98 86 1226 8316
Fax
Email
safarabadimahdi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak university of medical sciences
Full name of responsible person
Korosh Rezayi
Position
Bachelor of Nursing
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Arak.
City
Arak
Postal code
Phone
+98 86 1471 3505
Fax
Email
rezaeikorosh0@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences.
Full name of responsible person
Mahdi Safarabadi
Position
Student of MA Nursing Special
Other areas of specialty/work
Street address
Vali Asr hospital, Arak university of Medical Sciences, Arak.
City
Arak
Postal code
Phone
+98 86 1226 8316
Fax
Email
safarabadimahdi@yahoo.comdaesmaili@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)