The aim of this study is to evaluate the effects of semisolid dosage form prepared from Falcaria vulgaris on bed sore patients
Design
All patients who admitted in Emam khomeini hospital at Kermanshah University of Medical Sciences which suffering from bed sore or any other that admitted with any sing of bed sore will selected and guide the accompanying patients about the herbal medicine. They informed that the drug will be added to previous treating.
Settings and conduct
All patients who admitted in Emam khomeini hospital at Kermanshah University of Medical Sciences which suffering from bed sore or any other that admitted with any sing of bed sore will selected and guide the accompanying patients about the herbal medicine. They informed that the drug will be added to previous treating.
Participants/Inclusion and exclusion criteria
All admitted patients in Emam Khomeini hospital Kermanshah University of Medical Sciences suffering from bed sore
Intervention groups
Selected patients and their companions will take information about the investigational drug, then the drug administered on bedsores and injuries
Main outcome variables
During treatment, wounds will be scanned and evaluated according to the size and deep. the wound samples will be prepared and study the pathological specifications by a pathology specialist.
according to braden criteria different parameters like sensory perception, skin humidity, physical activity, mobility, nutrition condition, friction and skin tensile will be studied. pass medical history and habit history (alcoholic and opium addiction) will be interested in selected patients.
the pain score of patients will be studied if it is possible
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130722014106N6
Registration date:2018-12-31, 1397/10/10
Registration timing:registered_while_recruiting
Last update:2018-12-31, 1397/10/10
Update count:0
Registration date
2018-12-31, 1397/10/10
Registrant information
Name
Reza Tahvilian
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6482
Email address
rtahvilian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-06, 1397/08/15
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the clinical effects of semisolid dosage form using Falcaria vulgaris on bed sore patients
Public title
Studying the clinical effects of semisolid dosage form using Falcaria vulgaris on bed sore patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with bed sore in Emam Khomeini hospital Kermanshah Univesity of medical sciences
Exclusion criteria:
patient under anti neoplastic drug therapy
patients receiving immunosuppressive drugs
patients with cancer at end stage
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
No. 5116, Emam Khomeini hospital Naglieh Avenu
City
kermanshah
Province
Kermanshah
Postal code
6718743161
Approval date
2018-10-10, 1397/07/18
Ethics committee reference number
IR.kums.rec. 1397.589
Health conditions studied
1
Description of health condition studied
bed sore
ICD-10 code
S01.00XD
ICD-10 code description
Unspecified open wound of scalp, subsequent encounter
Primary outcomes
1
Description
length and wide of wound, exodus and type of tissue
Timepoint
first day, first to sixth week
Method of measurement
taking pic. and measuring the size of wound dimensions, type of tissue by clinical evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: bed sore patients
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini hospital
Full name of responsible person
Dr. Hossein Amiri
Street address
No. 5116, Emam Khomeini hospital Naglieh Avenu
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3727 5054
Fax
+98 83 3727 5054
Email
rtahvilian@kums.ac.ir
Web page address
http://www.kums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3838 4185
Fax
+98 83 3838 4185
Email
rtahvilian@kums.ac.ir
Web page address
http://www.kums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Neda Shahbazi
Position
Quality improvement office
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Kermanshah, Naghlieh Avenu Emam khomeini hospital
City
kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3727 5054
Fax
+98 83 3727 5054
Email
rtahvilian@kums.ac.ir
Web page address
http://www.kums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hossein Amiri
Position
Hospital manager
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No. 5116, Emam Khomeini hospital Naglieh Avenu
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 5055
Email
rtahvilian@kums.ac.ir
Web page address
http://www.kums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Neda Shahbazi
Position
Quality improvement office
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Naghlieh Avenu
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 5054
Fax
+98 83 3728 5054
Email
rtahvilian@kums.ac.ir
Web page address
http://www.kums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available