Objectives: determination of therapeutic effects of Q. infectoria gall extract on pressure ulcer in patients with stroke in Farshchian Hospital of Hamadan in the years 96-97. Design: a double blind randomized clinical trial with control and placebo. Setting and conduct: the eligible hospitalized patients in department of neurology and ICU of Farshchian Hospital with cerebral palsy due stroke will be enrolled into the trial. Inclusion criteria: patients with 2/5 or more of paralysis due one-way stroke and with pressure ulcer; patients who score 16 or less in Norton scale. Exclusion criteria: patient death or transfer to another health center; patient with necrotic wound due pressure ulcer at the beginning of the study; positive response to allergy test of Q. infectoria gall extract; progression of pressure ulcer to higher stages during the study. Intervention group: topical application of Phenytoin once daily and topical application of Q. infectoria gall 12 hours later. Control group: topical application of Phenytoin once daily and topical application of placebo 12 hours later. Primary outcome: progression of pressure ulcer to higher grades than initiation of treatment. Secondary outcome: assessing local reactions such as rash, hives, or redness.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017080435420N2
Registration date:2017-08-17, 1396/05/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-17, 1396/05/26
Registrant information
Name
Dara Dastan
Name of organization / entity
School of Pharmacy, Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1590
Email address
d.dastan@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Thchnology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-08-06, 1396/05/15
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effect of Quercus infectoria gall on pressure ulcer in patients with cerebral palsy due stroke
Public title
Evaluation of therapeutic effect of Quercus infectoria gall on pressure ulcer in patients with cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with 2/5 or more of paralysis due one-way stroke and with pressure ulcer; patients who score 16 or less in Norton scale. Exclusion criteria: patient death or transfer to another health center; patient with necrotic wound due pressure ulcer at the beginning of the study; positive response to allergy test of Q. infectoria gall extract; progression of pressure ulcer to higher grades during the study.
Age
From 37 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2017-07-10, 1396/04/19
Ethics committee reference number
IR.UMSHA.REC.1396.307
Health conditions studied
1
Description of health condition studied
Pressure ulcer
ICD-10 code
L89.9
ICD-10 code description
Decubitus ulcer and pressure area, unspecified
Primary outcomes
1
Description
Grade of pressure ulcer
Timepoint
At baseline and then daily for two weeks
Method of measurement
Through physical examination
Secondary outcomes
1
Description
Assessing local reactions such as rash, hives, or redness
Timepoint
24 hours later
Method of measurement
Through physical examination
Intervention groups
1
Description
Intervention: local application of Phenytoin cream 1% once daily in areas susceptible to ulcer (sacrum; iliac; spinal cord; elbow; waist; shoulder; auricle; buttock; heel and ankle) to the extent that cover the wound area and local application of Q. infectoria gall extract in the cream tube that is similar to placebo at 12 hours later for two weeks.
Category
Treatment - Drugs
2
Description
Control: local application of Phenytoin cream 1% once daily in areas susceptible to ulcer (sacrum; iliac; spinal cord; elbow; waist; shoulder; auricle; buttock; heel and ankle) to the extent that cover the wound area and local application of placebo in the cream tube that is similar to drug at 12 hours later for two weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Masoud Ghiasian
Street address
Farshchian Hospital, Mirzadeh Eshgi Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Science, Shaheed Fahmideh Ave.
City
Hamadan
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 and Technology, Hamadan 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
School of Pharmacy
Full name of responsible person
Dara Dastan
Position
Ph.D of Phytochemistry, Assistant Professor
Other areas of specialty/work
Street address
school of Pharmacy, Hamadan University of Medical Science, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1590
Fax
Email
d.dastan@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Medicine
Full name of responsible person
Masoud Ghiasian
Position
M.D. of Neurology, Assistant Professor
Other areas of specialty/work
Street address
School of Medicine, Hamadan University of Medical Science, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0462
Fax
Email
Masoud_ghiasian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Pharmacy
Full name of responsible person
Dara Dastan
Position
Ph.D of Phytochemistry, Assistant Professor
Other areas of specialty/work
Street address
School of Pharmacy, Hamadan University of Medical Science, Shaheed Fahmideh Ave.
City
Postal code
Phone
+98 81 3838 1590
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)