This study will be done with aim to investigate the effectiveness of a species of Scrophularia affecting wound repair. This is non-blinded clinical trial. The study population will be included all patients who due to injury from an accident, bed sores and diabetic ulcers will refer to the dermatologist in Kermanshah city. A total of 30 eligible patients that more than 3 days has not passed from wounding and the size of the wound has not caught more than 10% of body surface, will be selected in available method and will be assigned to tow experimental and control groups. Patients with secondary infection; Pregnant or lactating women; Patients treated with immunosuppressant drugs and patients with infected wounds that require treatment with antibiotics; Patients who take drugs with wound healing properties such as corticosteroid will excluded from the study. In this study, formulation of 10% of this herb will be used as a vanishing cream in experimental group. No intervention will be done in control group and usual cream will be used. Then its effect on the wound healing as a reduction of wound area (in percent) during the 7, 14 and 28 days will investigated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092014333N57
Registration date:2016-10-26, 1395/08/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-26, 1395/08/05
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2016-10-16, 1395/07/25
Expected recruitment end date
2017-07-16, 1396/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of an herbal semisolid dosage form of Scrophularia for scar treatment
Public title
The effect of a species of Scrophularia on wound repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: More than 3 days has not passed from wounding; The size of the wound has not caught more than 10% of body surface.
Exclusion criteria: Patients with secondary infection; Pregnant or lactating women; Patients treated with immunosuppressant drugs and patients with infected wounds that require treatment with antibiotics; Patients who take drugs with wound healing properties such as corticosteroid.
Age
From 3 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2016-05-11, 1395/02/22
Ethics committee reference number
kums.rec.1395.81
Health conditions studied
1
Description of health condition studied
Bedsore
ICD-10 code
L89.2
ICD-10 code description
Stage III decubitus ulcer
Primary outcomes
1
Description
Wound area
Timepoint
Baseline, days of 7, 14 and 28
Method of measurement
Visit by dermatologist
Secondary outcomes
empty
Intervention groups
1
Description
Formulation of 10% of this herb will be used as a vanishing cream in experimental group for a month.
Category
Treatment - Drugs
2
Description
No intervention will be done in control group and usual cream will be used
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
DDoctor Ebrahimi Clinic
Full name of responsible person
Maryam Ghaderi
Street address
Hajidaee Clinic, Golestan Square
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
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, Kermanshah 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Tahvilian
Position
Pharmaceutics
Other areas of specialty/work
Street address
School of Pharmacy, University of Medical Sciences, ParastarBoulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6482
Fax
Email
rtahvilian@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Maryam Ghaderi
Position
Student of Pharmacy
Other areas of specialty/work
Street address
School of Pharmacy, University of Medical Sciences, ParastarBoulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6482
Fax
Email
m_ghadery91@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)