Objectives: To determine the efficacy and safety of topical medicinal products (violet almond oil) to reduce fever in children 2 to 7-year-old and to design an intervention pattern for children with fever
Design: In a pilot study children 2- year old with 38-40 celecius degree tympanic tempreture randomly devide into two groups. drug(violet almond oil topical) group and the placebo(mineral oil) group. Both receive standard drug.
method: First, the fever is recorded in both groups. Then 5 drops of almond oil around the belly rubbed. In Group B with 5 drops of mineral oil is done. Fever Chech and recorded every half hour. If there is a fever after 1 hour in each of the two groups given 5 mg per kg of acetaminophen.
Participants Inclusion criteria: informed consent of parents Lack of medical assistance or other methods of medicinal plants for four hours before the Study no history of skin allergy to herbal medicines
Interventions: classic treatment in both groups - local drug(violet- almond oil) and placebo (mineral oil)
The main outcome variables: initial result of the decrease in temperature - a second dose of acetaminophen
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017040723722N2
Registration date:2017-05-10, 1396/02/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-10, 1396/02/20
Registrant information
Name
Vahid tafazoli ali
Name of organization / entity
shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3234 5145
Email address
stud4469948004@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for researchو shiraz university of medical sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
investigation of Efficacy and safety of topical application of almond violet oil on reducing the fever of febrile 2-7 years old children’
Public title
efficacy of violet oil in fever
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Parental informed consent to participate in the study; Lack of medical assistance or other methods of medicinal plants for four hours before the start of the study; 2 to 7-year-old patient with a temperature of 40-38 ° C temporal; No history of skin allergy to herbal medicines (determined by asking history of allergy to any local herbal medicine); No wound in the navel area
exclusion criteria: Ear temperature above 40 degrees; History of allergy to herbal medicines (determined by asking history of allergy to any local herbal medicine); The risk of seizures during the study; Cancel parents collaborated on the study; Patients with a history of seizures successive fever; Hypersensitivity to acetaminophen; Get pyretic 4 hours prior to arrival; Need emergency treatment; Being dehydrated patients with severe situation
Age
From 2 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
randomized numbers table used for randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
shiraz- Imam Hosein square
City
shiraz
Postal code
Approval date
2018-03-13, 1396/12/22
Ethics committee reference number
IR.sums.rec.1395.203
Health conditions studied
1
Description of health condition studied
Other specified fever
ICD-10 code
R50.8
ICD-10 code description
Fever with chills Fever with rigors Persistent fever
Primary outcomes
1
Description
fever degree
Timepoint
every 30 minute after intervention
Method of measurement
tympanic termometer
Secondary outcomes
1
Description
classic drug dose
Timepoint
one hour
Method of measurement
register shit
Intervention groups
1
Description
acetaminophane syrup 5 mg/kg at first and every hour if fever exist, mineral oil d drops at first and at the end (after 4 hours)
Category
Placebo
2
Description
acetaminophane syrup 5 mg/kg at first and every hour if fever exist, violet-almond oil d drops at first and at the end (after 4 hours)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir oncology hospital
Full name of responsible person
mahdi shahriari
Street address
shiraz-
City
shiraz- Amir oncology hospital- pediatric oncology department
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, shiraz university of medical science
Full name of responsible person
mohsen skandari
Street address
shiraz zand blvd
City
shiraz
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, shiraz 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
shiraz university of medical sciences
Full name of responsible person
vahid tafazoli
Position
Ph.D
Other areas of specialty/work
Street address
shiraz zand blvd 36 alley suit 2856 of Imam Hasan dorm
City
shiraz
Postal code
7135746661
Phone
+7 132352513
Fax
+7 135746661
Email
mihan5511@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
shiraz university of medical sciences
Full name of responsible person
majid nimroozi
Position
Assistant Professor
Other areas of specialty/work
Street address
shiraz Imam hosein square
City
shiraz
Postal code
7135746660
Phone
+7 132083313
Fax
Email
mnimrouzi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
shiraz university of medical sciences
Full name of responsible person
vahid tafazoli
Position
Ph.d
Other areas of specialty/work
Street address
shiraz zand blvd alley 36 Imam Hasan dorm n.2856
City
shiraz
Postal code
7135746661
Phone
+7 1335243024
Fax
Email
mihan5511@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)