This study is an intervention. Patients are children under 15 years old with hemangioma. If they have hemangioma with organ malfunction, rapid progressing and large hemangioma will qualify for treatment with propranolol (mean dose 2 mg/kg twice a day for 6 month). Patients with cardiovascular disease are not involved. Their relapse will be followed up after 6 month. Control group in this study because of limitation in number of patients and absence of control group in similar study is not adopted.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014041817325N1
Registration date:2014-06-30, 1393/04/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-30, 1393/04/09
Registrant information
Name
Afshin Fathi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1226 1610
Email address
a.fathi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of propranolol efficacy on pediatric hemangioma
Public title
Propranolol in treatment of hemangioma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with hemangioma under 15 years old
Exclusion criteria: Patients with cardiovascular disease; patients with history of low blood sugar; patients use another drugs last 6 months.
Age
From 1 day old to 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
There is no control group in this study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Daneshgah St, Janbazan Sq
City
Ardabil
Postal code
Approval date
2012-07-29, 1391/05/08
Ethics committee reference number
arums.rec.93.33
Health conditions studied
1
Description of health condition studied
Hemangioma
ICD-10 code
D18.0
ICD-10 code description
Hemangioma, any site
Primary outcomes
1
Description
Regression of hemangioma (decrease in size)
Timepoint
1 week, 6month, 1 year
Method of measurement
Watchful, sonography if needed
Secondary outcomes
1
Description
Decrease blood sugar
Timepoint
In first visit, after 1 week
Method of measurement
With glucometer
Intervention groups
1
Description
Propranolol 2 mg/kg twice a day for 6 month in case group. There is no control group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu - Ali Hospital
Full name of responsible person
Dr.Afshin Fathi
Street address
Varzesh Sq. Ardabil
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Parvane Naftchi
Street address
Daneshgah St, Janbazan Sq
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Nava Soleymani
Position
M.D, Physician
Other areas of specialty/work
Street address
Maryam pansion, Qiam Sq
City
Ardabil
Postal code
Phone
+98 45 1333 0633
Fax
Email
navasoleimani@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Afshin Fathi
Position
Chairman, Specialist
Other areas of specialty/work
Street address
Bu - Ali Hospital, Varzesh Sq
City
Ardabil
Postal code
Phone
+98 45 1225 2251
Fax
Email
a.fathi@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Nava Soleymani
Position
M.D, Physician
Other areas of specialty/work
Street address
Maryam pansion, Qiam Sq
City
Ardabil
Postal code
Phone
+98 45 1333 0633
Fax
Email
navasoleimani@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)