Protocol summary

Summary
Methicillin-resistant Staphylococcus aureus (MRSA) is a major cause of nosocomial infections word wide. Normally MRSA is present at health care centers and hospitals but in recent years have also occurred in community. On the other hand reports of MRSA resistant to other antibiotics lead us to compare the efficacy of antibiotics like Linezolid, Rifampin, Vancomycin, Gentamicin, Teicoplanin, Chloramphenicol, Mupirocin, Neomycin and Citrus essential oil , Satureja Khuzestanica extarct and Tea tree oil on 80 Nasal MRSA sample collected from hospitalized patient. After comparing the average diameter of inhibition zone, tea tree oil has great effect in inhibiting the growth of MRSA. According to the result of the first phase 8% Tea tree oil Nasal ointment prepared. To assess the effect of the Tea tree oil nasal ointment 50 patient with positive Nasal MRSA divided in two groups of 25. Group A are patient who are going on treatment with tea tree oil Nasal ointment and group B are patient who are going under treatment with Mupirocin 2 %. Both groups apply ointment 3 times a day for 5 day. All 50 patients monitored for Nasal MRSA by the end of day 5. Results in both groups were similar.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201603073106N29
Registration date: 2017-04-21, 1396/02/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-04-21, 1396/02/01
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-05-15, 1395/02/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effectiveness of 8 percent Tea Tree oil Nasal Ointment and Mupirocin ointment for NASAL MRSA decolonizaion in hospitalized patients.
Public title
Assesment of Tea Tree Oil Nasal ointment for eradication of NASAL MRSA
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Patient with positive MRSA between 15 and 60 years old in khatam al anbia hospital Exclusion citeria: children; pregnant women; sever systemic infection; patients receiving chemotherapy; chronic use of antibiotics; patient with sensivity
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
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
Pharmaceutical Science Branch of Islamic Azad university
Street address
No.99, Yakhchal street, Dr. Shariati Avenue, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-12-22, 1394/10/01
Ethics committee reference number
IR.IAU.PS.REC.1394.2

Health conditions studied

1

Description of health condition studied
Nasal Methicillin-Resistant Staphylococcus aureus infection
ICD-10 code
U80.1
ICD-10 code description
Bacterial agents resistant to antibiotics

Primary outcomes

1

Description
Nasal bacterial cultures
Timepoint
Before intervention- after5 day
Method of measurement
Nasal bacterial cultures

Secondary outcomes

1

Description
Nasal irritation-Itchy nose-headache
Timepoint
Every day
Method of measurement
Question and answer

Intervention groups

1

Description
Intervention group: apply 8 percent Tea tree oil nasal ointment 3 times a day for 5 day
Category
Treatment - Drugs

2

Description
Intervenions: control group: apply Mupirocin 2 percent ointment 3 times a day for 5 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Khatamal Ol Anbia Hospital
Full name of responsible person
Targol sheibani
Street address
Khatam Ol Anbia Hospital, Rashid Yasemi Street, Above Mirdamad Blvd, Vali-Ye-Asr St,Tehran,Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Pharmaceutical Science Branch of Islamic Azad University
Full name of responsible person
Dr. Sepideh Arbabi Bidgoli
Street address
No.99, Yakhchal street, Dr. Shariati Avenue, Tehran ,Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmaceutical Science Branch of Islamic Azad University
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
Pharmaceutical Science Branch of Islamic Azad University
Full name of responsible person
Dr. Mehdi Rajabi
Position
Assistant professor, Head of Department
Other areas of specialty/work
Street address
No.99, Yakhchal street, Dr. Shariati Avenue, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2264 0051
Fax
Email
mehdirj@aol.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Pharmaceutical Science Branch of Islamic Azad University
Full name of responsible person
Dr. Mehdi Rajabi
Position
Assistant professor, Head of Department
Other areas of specialty/work
Street address
No.99, Yakhchal street, Dr. Shariati Avenue, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2264 0051
Fax
Email
mehdirj@aol.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Pharmaceutical Science Branch of Islamic Azad university
Full name of responsible person
Targol sheibani
Position
pharmacist
Other areas of specialty/work
Street address
No.99, Yakhchal street, Dr. Shariati Avenue, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2264 0051
Fax
Email
targol.sheibani@yahoo.com
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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