Comparison the effect of the topical Plantago major hydro-alcoholic extract versus placebo on treatment of grade1 pressure ulcer in patients with paralysis secondary to brain stroke: a triple blind randomized clinical trial
Objectives: To compare the effect of the topical Plantago major hydro-alcoholic extract versus placebo on treatment of grade1 pressure ulcer in patients with paralysis secondary to acute stroke
Design: a triple blind randomized clinical trial.
Setting and conduct: The eligible patients with paralysis secondary to brain stroke who will refer to Farshchian Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Complete bedrest patients with paralysis secondary to brain stroke; grade1 pressure ulcer.
Exclusion criteria: Grade 2 pressure ulcer; sensitivity to Plantago and its products;
Intervention group: Using topical Phenytoin cream 1% on the grade 1 pressure ulcers once a day for 2 weeks plus Plantago major hydro-alcoholic extract once a day for 2 weeks.
Control group: Using topical Phenytoin cream 1% on the grade 1 pressure ulcers once a day for 2 weeks plus placebo once a day for 2 weeks
Primary outcome: Assessing the grade 2 pressure ulcer or higher grades 2 weeks after treatment through physical examination.
Secondary outcome: Assessing local reactions such as rash, hives, or redness 2 weeks after treatment through physical examination.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201609209014N117
Registration date:2016-09-22, 1395/07/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-09-22, 1395/07/01
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-10-06, 1395/07/15
Expected recruitment end date
2016-10-08, 1395/07/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of the topical Plantago major hydro-alcoholic extract versus placebo on treatment of grade1 pressure ulcer in patients with paralysis secondary to brain stroke: a triple blind randomized clinical trial
Public title
Comparison the effect of the topical Plantago major hydro-alcoholic extract versus placebo on treatment of grade1 pressure ulcer in patients with paralysis secondary to brain stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Complete bedrest patients with paralysis secondary to brain stroke; grade1 pressure ulcer.
Exclusion criteria: Grade 2 pressure ulcer; sensitivity to Plantago and its products;
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-09-17, 1395/06/27
Ethics committee reference number
IR.UMSHA.REC.1395.295
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
Assessing the grade 2 pressure ulcer or higher grades
Timepoint
2 weeks after treatment
Method of measurement
through physical examination
Secondary outcomes
1
Description
Assessing local reactions such as rash, hives, or redness
Timepoint
2 weeks after treatment
Method of measurement
through physical examination
Intervention groups
1
Description
Using topical Phenytoin cream 1% on the grade 1 pressure ulcers once a day for 2 weeks plus Plantago major hydro-alcoholic extract once a day for 2 weeks
Category
Treatment - Drugs
2
Description
Using topical Phenytoin cream 1% on the grade 1 pressure ulcers once a day for 2 weeks plus placebo once a day for 2 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Zahra Niroomandi
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid 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 the 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
Farshchian Hospital
Full name of responsible person
Zahra Niroomandi
Position
Student of Pharmacology
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
zahra_niroomandi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Pharmacology
Full name of responsible person
Dr Sara Ataei
Position
Pharmacologist
Other areas of specialty/work
Street address
School of Pharmacology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3388 0572
Fax
Email
s.ataei@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)