Protocol summary

Summary
We compared the effect of tail black tea with boiled water as adjust treatment on the severity of infant’s conjunctivitis. This was a randomized controlled trial conducted in the Pediatric Clinic of Amir Kabir Hospital in Arak from September 2009 until November 2010. A total of 165 infants were randomized into one of the 3 following treatment groups to receive either eye washing with tail black tea as well as ophthalmic erythromicine, onitment ./5% and sulfastamide ophtalmic solution 10% tid, eye washing with boiled water as well as antibiotics or antibiotics only, for 7 days. To wash the eyes, tail black tea or boiled water was used from medial to lateral using a strile swab before antibiotic use. Duration of treatment and the severity of conjunctivitis at first, 3rd and 7th days after the intervention were determined and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201011281839N2
Registration date: 2010-12-22, 1389/10/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-12-22, 1389/10/01
Registrant information
Name
Mahtab Attarha
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 861417350009
Email address
m.attarha@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Arak University of Medical Sciences
Expected recruitment start date
2009-06-17, 1388/03/27
Expected recruitment end date
2009-12-18, 1388/09/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of tail black tea with boiled water as adjust treatment in severity of infants conjunctivitis referred to Amir Kabir Hospital Pediatric Clinic 1388
Public title
Complementary treatment and infants Conjunctivitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 1-12 month, conjunctivitis (muco purulent eye discharge, sticky eyelids, edema and erythema), no underlying or congenital disease, literate mother Exclusion criteria: Allergy to brewed black tea, lack of response to questionnaire, moving to another location, maternal or neonatal infection during the study so that it requires antibiotic therapy, Non-compliance
Age
From 1 year old to 1 year old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 55
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
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
Third floor,Educational Building Department, Arak Medical Sciences University, Arak, Iran
City
Arak
Postal code
Approval date
2009-06-17, 1388/03/27
Ethics committee reference number
4-60-88

Health conditions studied

1

Description of health condition studied
Infants Conjunctivitis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
severity of disease
Timepoint
3rd and 7th days
Method of measurement
Score from 0 to 3

2

Description
Duration of disease
Timepoint
3rd and 7th days during treatment
Method of measurement
No of days

Secondary outcomes

1

Description
Epiphora, burning eye
Timepoint
3rd and 7th days during treatment
Method of measurement
from 0 to 3

Intervention groups

1

Description
Eye washing with a teaspoon of Lahijan tea in a cup of boiling water, using a sterile cotton swab, before the application of antibiotics as follows: erythromycin ointment eye 5 / 0 percent with a length of a finger inside each eye, Sulfacetamid ophtalmic drop10%, (2 drops per eye) 3-4 times a day
Category
Treatment - Other

2

Description
Eye washing with cool previously boiled water, using a sterile cotton swab, before the application of the following antibiotics: erythromycin ointment eye 5 / 0 percent with a length of a finger inside each eye, Sulfacetamide ophtalmic drop10%, (2 drops per eye) 3-4 times a day
Category
Treatment - Other

3

Description
Control group: Only antibiotics: erythromycin ointment eye 5 / 0 percent with a length of a finger inside each eye, Sulfacetamide ophtalmic drop10%, (2 drops per eye) 3-4 times a day
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Peditric Clinic of Arak University of Medical Sciences
Full name of responsible person
Mahtab Attarha & Parsa Yosefi
Street address
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chanceller of Arak University of Medical Sciences
Full name of responsible person
Davood Hekmatpoo
Street address
Third floor,Educational Bulding Departmant,Arak Medical Sciences University, Arak,Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chanceller 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
Vice Chanceller for research, Arak University of Medical Sciences
Full name of responsible person
Mahtab Attarha
Position
Instructor , Academic member
Other areas of specialty/work
Street address
Second floor Blue Wing Pardis Bulding Complex, Arak Medical Sciences University, Sardasht Sq, Arak Iran
City
Arak
Postal code
Phone
+98 86 1417 3516
Fax
Email
mahtab_at2004@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Vice Chanceller for research of Arak University of Medical Sciences
Full name of responsible person
Mahtab Attarha & Parsa Yosefi MD
Position
Instructor, Acaedemic member
Other areas of specialty/work
Street address
Second floor, Blue Wing Pardis Bulding Complex,Arak Medical Sciences University, Arak,Iran
City
Arak
Postal code
Phone
+98 86 1417 3516
Fax
Email
mahtab_at2004@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Vice Chanceller for research, Arak University of Medical Sciences
Full name of responsible person
Mahtab Attarha
Position
Instructor, Academician
Other areas of specialty/work
Street address
City
Arak
Postal code
Phone
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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