Protocol summary

Summary
Paederus dermatitis, also known as dermatitis linearis is a peculiar irritant contact dermatitis characterized by erythematous and bullous lesions of sudden onset on exposed areas of the body. Iranian traditional medicine uses the S. ebulus in treating some inflammatory cases such as, bee and nettle bites, arthritis and sore-throat. In addition, it has been reported to be anti-bacterial, antioxidant, convenient in treatment of burns and infectious wounds, edema, eczema, urticaria, inflammation and rheumatism. These effects gave us a solid basis to make use of S. ebulus in treatment of paederus dermatitis. This study was designed to evaluate the clinical efficacy of S. ebulus 5% solution in patients affected by paederus dermatitis. Fruit were dried at room temperature and coarsely ground before extraction. Weighed amount of powdered sample was fractionated by successive solvent extraction at room temperature by percolation with hexane then ethyl acetate and finally methanol successively. To evaluate the clinical effect of ethanolic 5% solution, 60 patients will include blind and randomly in two groups, that administer S. ebulus ethanolic 5% solution or ethanol 70. All of patients will use a local hydrocortisone ointment too.The effects of drugs in terms of affecting on itching, burning, pain, inflammation, healing rate, drying the wound and infections will study. Four levels, namely, ineffective (value zero), average effect (value one), good effect (value two) and great effect (value three) chose for evaluation. All patients were visited or asked every 12 hr. The preparations will use locally 3 times a day. Only patient with the beginning of lesion less than 24 hours will enter to study. Any adverse drug reaction will considered, too.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201302132342N3
Registration date: 2013-03-09, 1391/12/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-03-09, 1391/12/19
Registrant information
Name
Mohammad Reza Rafati
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3083
Email address
mrrafati@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2011-01-02, 1389/10/12
Expected recruitment end date
2011-10-01, 1390/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Sambucus ebulus 5% solution in the treatment of Paederus Dermatitis
Public title
The effect of Sambucus ebulus in the treatment of Paederus Dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age: 10-60 years; Diagnosis of Paederus dermatitis; Lasting at least 24 hours from the beginning wound signs. Exclusion criteria: Age out of mentioned range; Pregnancy; Diseases or drug using associated with impaired immune system or absence of natural skin repair
Age
From 10 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Mazandaran University of Medical Sciences, Vice-chancellor for research, Dr. Mohammad Reza Haghshena
Street address
Moallem square
City
Sari
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
54-1389

Health conditions studied

1

Description of health condition studied
Paederus dermatitis
ICD-10 code
L24.9
ICD-10 code description
Irritant contact eczema NOS

Primary outcomes

1

Description
Pain
Timepoint
At the beginning of study and then every 12 hours
Method of measurement
questionare

2

Description
Burning
Timepoint
At the beginning of study and then every 12 hours
Method of measurement
questionare

3

Description
Lesion size
Timepoint
At the beginning of study and then every 24 hours
Method of measurement
Centimeter square

Secondary outcomes

1

Description
Treatment duration
Timepoint
The end of treatment
Method of measurement
Hour

2

Description
Incidence of infection
Timepoint
Each 24 hours
Method of measurement
Physician examination

Intervention groups

1

Description
Intervention group will receive S. ebulus fruit extract 5% solution and hydrocortisone ointment for locally 3 times a day.
Category
Treatment - Drugs

2

Description
Patients in control group will receive ethanol 70° and hydrocortisone ointment for locally 3 times a day.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Booalisina hospital
Full name of responsible person
Dr Masoud Golpur
Street address
Skin office, Pasdaran street
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences, Vice-chancellor for research
Full name of responsible person
Dr Haghshenas
Street address
Moallem square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences, Vice-chancellor for research
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
College of Pharmacy, Mazandaran University of Medical Sciences
Full name of responsible person
Dr Mohahammadali Ebrahimzadeh
Position
Ph.D
Other areas of specialty/work
Street address
20th Km, Farahabad road, College of Pharmacy, Mazandaran University of Medical Sciences
City
Sari
Postal code
Phone
+98 15 1354 3083
Fax
Email
zadeh20@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
College of Pharmacy, Mazandaran Uiversity of Medical Sciences
Full name of responsible person
Dr Mohammadreza Rafati
Position
Ph.D
Other areas of specialty/work
Street address
College of Pharmacy, Mazandaran Uiversity of Medical Sciences, 20th Km, Farahabad road
City
Sari
Postal code
Phone
+98 15 1354 3083
Fax
Email
mrrafati@mazums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
College of pharmacy, Mazandaran University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Rafati
Position
Other areas of specialty/work
Street address
College of pharmacy, Mazandaran University of Medical Sciences, 20th Km, Farahabad road
City
Sari
Postal code
Phone
+98 15 1354 3083
Fax
Email
mrrafati@mazums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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