The aim of this study is investigating the effect of a chosen local herbal drug from Persian medicine in the treatment of cutaneous lesions caused by Pemphigus vulgaris. This study will be performed on 20 patients with confirmed diagnosis who are hospitalized in the dermatology department of shahid Faghihi hospital; dependent on shiraz University of Medical Sciences; who had signed informed consent.
Right- or left-sided lesions will randomized for treatment with Iranian topical medicinal drug or placebo.
The treatments are applied locally twice a day and the wounds are evaluated in 0, 15 and 30 days after starting the treatments by examining the wound extent, recovery rate, and Epithelialization. The measurements are performed with ruler and the widest wound diameter is measured. By using the Epithelialization index equation, the improvement of Epithelialization could be quantified. Lastly by using statistical analysis, the effects of medicinal product will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013120815720N1
Registration date:2014-04-06, 1393/01/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-06, 1393/01/17
Registrant information
Name
fatemeh atarzadeh
Name of organization / entity
Tehran univercity of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5560 1274
Email address
f_atarzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2013-12-10, 1392/09/19
Expected recruitment end date
2014-07-10, 1393/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effect an Iranian traditional medicinal local drug and placebo in the treatment of cutaneous lesions of Pemphigus Vulgaris.
Public title
The efficacy of an Iranian traditional medicinal drug in the treatment of cutaneous lesions of Pemphigus Vulgaris.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients who has confirmed Pemphigus vulgaris in clinical manifestation and pathology and direct immunofluorescence; who has been admitted for the first time or in the relapse of disease; having two symmetrical lesions on the trunk or extremities; signing of informed consent.
exclusion criteria:
Pregnant or nursing patients; having drug sensitivity; face lesions; infected lesions.
Age
No age limit
Gender
Both
Phase
N/A
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
Research Institute for Islamic and Complementary Medicine (RICM)
Street address
Pyrnia Alley, Lalezarno Ave. Jomhoori Eslami St. Tehran, IRAN
City
Tehran
Postal code
Approval date
2013-05-27, 1392/03/06
Ethics committee reference number
پ26/م ط/114
Health conditions studied
1
Description of health condition studied
Pemphigus vulgaris
ICD-10 code
L10.0
ICD-10 code description
Pemphigus vulgaris
Primary outcomes
1
Description
diameter of ُskin pemphigus lesions
Timepoint
0, 15, 30
Method of measurement
ruler (mm)
Secondary outcomes
1
Description
epithelization index
Timepoint
0, 15, 30
Method of measurement
Maximum diameter at the baseline - Maximum diameter at the end of study)/ Maximum diameter at the baseline * 100
Intervention groups
1
Description
applying local traditional medicinal gel drug to the lesion in intervention side twice daily in 30 days.
Category
Treatment - Drugs
2
Description
applying local placebo gel drug to the lesion in control side twice daily in 30 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital Shiraz
Full name of responsible person
Ladan Dastgheib
Street address
Zand Avenue, Shiraz, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Dariush Mahmoodi
Street address
Office of Vice Chancellor to Research, Third floor, Faculty of Triditional Medicine, Behesht St., Vahdat Eslami st., Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences, department-of-traditional-medicine
Full name of responsible person
Fatemeh Atarzadeh
Position
MD
Other areas of specialty/work
Street address
No. 59, Ghasrodasht, Shiraz
City
Shiraz
Postal code
7183894993
Phone
+98 71 1626 8875
Fax
Email
dr.atarzadeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences Faculty of Pharmacy
Full name of responsible person
Gholamreza Amin
Position
PHD
Other areas of specialty/work
Street address
Enghelab Street, Tehran University of Medical Sciences, School of Pharmacy
City
Tehran
Postal code
Phone
+98 21 6648 2609
Fax
Email
amin@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Iranian traditional medicine, Tehran University of Medical Sciences
Full name of responsible person
fatemeh atarzadeh
Position
MD
Other areas of specialty/work
Street address
Behesht Clinic, Behesht St., Vahdat-e Eslami st. (South Hafiz)
City
Tehran
Postal code
Phone
+98 71 1626 8875
Fax
Email
dr.atarzadeh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)