This study is a clinical trial. Sixty patients with second degree burn that are hospitalized at the Burn Unit of Hazrat Vali-Asr Hospital of Arak, Iran will be recruited. After signing the study informed consent and completing the study questionnaire (for assessing information on their injury and burn, the demographic specifications and economical-social status), the patients are are randomly allocated in the two groups of intervention (30 patients) and control (30 persons). In the beginning of the study, the wound status of the patients is assessed by the researcher by Bates-Jenson standard tool and the information on oxidative stress of the patient prior to intervention is collected by taking venous blood specimen which is usually prepared for routine tests. The blood specimen of patients is centrifuged and its serum is stored in -70 centigrade degree temperature. In addition to the ordinary treatment the participants receive in burn unit, the non-fast patients in intervention group, receive 100 cc liquids made of 3 grams lemon balm leaves drink prepared in 200 cc boiled water as left for 10 minutes to be brewed, twice a day in morning and evening between two meals for two weeks period. (The leave is brewed on indirect flame by a trained person). At the end of the first and second week, the wound situation is assessed again by researcher in both intervention and control groups by using the relevant tools. The information on oxidative stress level of the patients is determined by taking venous blood specimen after intervention in both intervention and control groups. The parameters on the status of the wound and oxidative stress are analyzed by statistical tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012312246N1
Registration date:2013-02-24, 1391/12/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-24, 1391/12/06
Registrant information
Name
Masumeh Abbasdust Arbastan
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8840 3119
Email address
m.abbasdost@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2012-12-10, 1391/09/20
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral Mellis officinalis on serum oxidative stress and second degree wound healing
Public title
Effect of Mellis officinalis on serum oxidative stress and second degree wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having burn between 15 to 50 percent of body surface; having age range from 18 to 15 years old; hospitalization in burn unit; non-fasting; not having underlying diseases such as thyroid disorders, diabetics, cancer or infectious diseases; no records of drugs abuse (alcohol, narcotic drugs, under treatment with sedatives and anti-depressants); volunteered to participate in the survey; not pregnant; no records of taking supplementary antioxidants and the burn is not caused by electricity (electric devices).
Exclusion criteria: refraining from continuing participation in the study; possible allergy to lemon balm; patient’s discharge; transfer to another center and death of the patient.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
school of nursing and Midwifery
City
arak
Postal code
Approval date
2012-11-26, 1391/09/06
Ethics committee reference number
91-137-10
Health conditions studied
1
Description of health condition studied
Second-degree burn
ICD-10 code
T29.2
ICD-10 code description
Burns of multiple regions, no more than second-degree burns mentioned
Primary outcomes
1
Description
burning wound healing
Timepoint
Baseline - the seventh day - the fifteenth day of the intervention
Method of measurement
bates-jensenWound assessment tool
2
Description
serum antioxidant levels
Timepoint
Baseline (pre-intervention) and the end of the intervention (the fifteenth day
Method of measurement
Tests measuring levels of serum antioxidants
Secondary outcomes
1
Description
Burned Wound pain
Timepoint
Baseline - the seventh day - the fifteenth day
Method of measurement
Numerical scale of 0-10
Intervention groups
1
Description
An infusion of lemon balm herb in the intervention group, 1.5 grams 1.5 grams 9 am to 9 pm Duration of intervention: 14 days. 5 ml venous blood (blood samples routinely taken from patients) in the first and fifteenth day is taken and serum antioxidant levels are measured .A second degree burn wound in the first and seventh and fifteenth days of the bats - Jensen tools are classified scored
Category
Treatment - Drugs
2
Description
No intervention is used in control groupe . A venous blood sample (5 ml) on the first and fifteenth day of the study is to measure serum antioxidant levels occurs., A second-degree burn wound in the first and seventh and fifteenth days of the bats tools - Jensen scores are classified.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital of Arak
Full name of responsible person
Miss Adam pira
Street address
Valiasr square, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Davood Hekmat Pou,- PhD Nursing - Surgery - Faculty - Director of Research and Information
Street address
Director of Research and Information,pardis building,basij square,sardasht,arak
City
Arak
Grant name
17500000ریال-شماره 840-به صورت پیمانی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Masumeh Abbasdust Aarbastan
Position
Master student of critical care nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Pardis building, Basij square, sardasht
City
Arak
Postal code
3848176941
Phone
+98 21 8840 3119
Fax
Email
m.abbasdost@arakmu.ac.ir; m.abasdust@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Kobra Rahzani
Position
Academic Staff - PhD Nursing - Surgical
Other areas of specialty/work
Street address
school of nursing and midwifery
City
Arak
Postal code
3848176941
Phone
+98 86 1417 3502
Fax
+98 41 73639
Email
k.rahzani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Masumeh Abbasdust Arbastan
Position
Master student of critical care nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Pardis building,Sardasht , Arak
City
Arak
Postal code
Phone
+98 21 8840 3119
Fax
Email
m.abbasdost@arakmu.ac.ir; m.abasdust@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)