The aim of this study was to evaluate the impact of the Althea officinalis on latex allergy among hospital operating room personnel of Arak. This study was a double-blind clinical trial, on 66 operating room personnel in Arak hospitals who are allergic to latex. They were randomly divided into two groups (8% and 5 ml aqueous extracts of Althea officinalis before and after wearing the gloves) and control distilled water (similar to the intervention group), respectively.
Before and after intervention, the samples were examined by a dermatologist and completed self-assessment questionnaire of “Symptom Severity of Natural latex allergy". Inclusion criteria included: allergy to latex, daily use of latex gloves. Exclusion criteria: pregnancy, use of corticosteroids, allergy to Althea officinalis. Finally, to assess the impact of the Althea officinalis on the symptoms of latex allergy .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014072614229N2
Registration date:2014-09-05, 1393/06/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-05, 1393/06/14
Registrant information
Name
Hadi Jafari manesh
Name of organization / entity
Arak University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3503
Email address
jafarimanesh@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Science
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2014-07-29, 1393/05/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of Alcea Althea with placebo on severity of latex allergy symptoms among operating room staffs in hospitals of Arak city.
Public title
Effect of Alcea Althea on latex allergy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included having a degree of latex allergy, aged between 18 and 60 years, working as an operating room personnel, and history of Latex gloves. Exclusion criteria included pregnancy, use of corticosteroids, use of medications associated with skin lesions, withdrew from the study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Double-blind study. Participants and the researcher is not aware of the materials that used in the study.
Subjects were randomly assigned into experimental and control groups by lottery.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Basij Sq. Arak
City
Arak
Postal code
3819693345
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
6- 139- 91
Health conditions studied
1
Description of health condition studied
latex allergy
ICD-10 code
Z88.8
ICD-10 code description
Personal history of allergy to other drugs, medicaments and biological substances
Primary outcomes
1
Description
latex allergy
Timepoint
Before and after 30 days
Method of measurement
The questionnaire contains natural latex allergy symptoms
Secondary outcomes
empty
Intervention groups
1
Description
Group 1 (intervention): 5 ml of 8% aqueous extract solution of flowers and roots of Althea officinalis, are used for 30 days, before and after using gloves.
Category
Treatment - Other
2
Description
Group 2 (control): 5 ml of placebo (sterile water), before and after, is used for 30 days, before and after using gloves
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Hadi Jafari Manesh
Street address
Rahahan Sq. Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Science
Full name of responsible person
Davood Hekmatpou
Street address
Basij Sq. Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Davood Hekmatpou
Position
Ph.D /Research Manager
Other areas of specialty/work
Street address
Basij Sq. Arak
City
Arak
Postal code
Phone
+98 86 3417 3645
Fax
+98 918 161 6539
Email
Dr_hekmat@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafari Manesh
Position
Master of Nursing
Other areas of specialty/work
Street address
Basij Sq. Arak
City
Arak
Postal code
Phone
+98 86334173503
Fax
Email
nurse_science@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafari Manesh
Position
Master of Nursing
Other areas of specialty/work
Street address
Basij Sq. Arak
City
Arak
Postal code
Phone
+98 86334173503
Fax
Email
Jafarimanesh@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)