The objective of randomized, double-blind, placebo-controlled study was to compare therapeutic effects of herbal Zofa ointment with Silversulfadiazin in burning therapy. Inclusion criteria are hospitalized second degree burn patients who accept to participate in the study. Exclusion criteria are children; people without consciousness or with mental disability; the elderly; pregnant women; immunocompromised patients; patients with drug sensitivity history. In this study, 20 second degree burn patients in the burn ward of Sina hospital that are willing to participate in the study are selected randomly. A double-blinded treatment of Herbal Zofa ointment and topical silversulfadiazine will be applied thrice daily on two second degree burns on each patient for the duration of two months. Physical examination by a dermatologist is performed after each application of the treatment measures. Photos are taken at the beginning and end of the treatment, mid-process if necessary, to compare the effects of the two drugs in terms of patients' recovery. The patient will undergo a recorded verbal questionnaire in regards to side effects, efficiency of treatment and recovery for the two individual treatments. This will continue periodically for two months. The primary outcome is pain and irritation, erythema and secondary outcome is the healing and less pain of wound.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201705119844N5
Registration date:2017-05-24, 1396/03/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-24, 1396/03/03
Registrant information
Name
Mehdi Amirnia
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1540 6612
Email address
amirniam@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tabriz University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effects of the herbad Zofa ointment with Silversulfadiazin in burning therapy
Public title
effects of the herbad Zofa ointment in burning therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: second degree burn patients hospitalized; patients who decline to participate in research.
exclusion criteria: the children; people without consciousness or mental disability; the elderly; pregnant women; immunocompromised patients; patients with drug sensitivity history.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
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
Tabriz University of Medical Sciences
Street address
Third floor, Central Building, Tabriz University of Medical Sciences, Gholgasht ave, Tabriz, Iran
City
Tabriz
Postal code
5163639888
Approval date
2014-08-04, 1393/05/13
Ethics committee reference number
IR.TBZMED.REC.1393.9383
Health conditions studied
1
Description of health condition studied
burns
ICD-10 code
T22.2
ICD-10 code description
Burn of second degree of shoulder and upper limb, except wrist and hand
Primary outcomes
1
Description
Pain
Timepoint
Before the study, two months after the study.
Method of measurement
VAS Scale
Secondary outcomes
1
Description
Wound healing
Timepoint
Before the study, two months after the study
Method of measurement
Clinical examination
Intervention groups
1
Description
Control group: silver sulfadiazine, topical ointment, three times in a day for two months.
Category
Treatment - Drugs
2
Description
Case group: Zofa, herbal topical ointment, three times in a day for two months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
burn ward of Sina hospital
Full name of responsible person
Dr Arman Javan Rozeghar
Street address
Tabriz University of Medical Sceince
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chanscellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Street address
Tabriz University of Medical Sciences, Daneshgah Avenue, Tabriz, East Azarbayjan, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chanscellor for research, Tabriz 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
Tabriz University of Medical Sceince
Full name of responsible person
Dr Arman Javan Rozeghar
Position
Dermatology Assistant
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Daneshgah Avenue, Tabriz, East Azarbayjan, Iran
City
Tabriz
Postal code
Phone
+98 41 3340 6612
Fax
Email
Mehamir46@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences, Daneshgah Avenue, Tabriz, East Azarbayjan, Iran
Full name of responsible person
Dr Efat Khodayan
Position
dermatologist
Other areas of specialty/work
Street address
Tabriz University of Medical Sceince
City
Tabriz
Postal code
Phone
+98 41 3340 6612
Fax
Email
drekhodaeiani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Arman Javan Rozeghar
Position
Dermatology Assistant
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)