The evaluation of the metformin efficacy as an adjuvant therapy in the treatment of patients with pemphigus in Mazandaran province.
Design
Clinical trial with community-based and pragmatic control group, with parallel groups, triple blind, randomized
Settings and conduct
Context: Adjuvant treatment of autoimmune diseases (Pemphigus vulgaris)
Place and method of study: Mazandaran University of Medical Sciences (skin clinics)
Blinded people: patients, researcher, data analyzer
Participants/Inclusion and exclusion criteria
Patients with definite diagnosis of Pemphigus Vulgaris and Foliacea can take part in the study based on their clinical profile, pathologic findings and direct and indirect immunofluorescence, the age of 18 and both sexes (female / male). People under the age of 18 and duration of diagnosis for more than 24 months are excluded from the study.
Intervention groups
control group:
Prednisolone plus metformin for placebo
Intervention group:
Metformin consumer as an adjuvant in the treatment of Pemphigus (plus to the main treatment)
Main outcome variables
IgG1 level; IgG3 Level; serum level of NFkB; serum level of TNFa
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170822035834N2
Registration date:2018-03-05, 1396/12/14
Registration timing:prospective
Last update:2018-03-05, 1396/12/14
Update count:0
Registration date
2018-03-05, 1396/12/14
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 3190
Email address
g.houshmand@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pilot Study of the Efficacy of Metformin as an Adjuvant Therapy in Patients with Pemphigus Vulgaris
Public title
Metformin in Pemphigus Vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People diagnosed with their disease, and clinical manifestations and laboratory findings related to pemphigus (skin manifestations, etc.) have been proven by a dermatologist. And hospitalized in the relevant department.
Individual consent to participate in the study
age more than 18
Exclusion criteria:
age less than 18
Duration of diagnosis is more than 24 months.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who come to the skin clinic will be randomly assigned to the study using RAS computer software. Therefore, this will be clinically randomized,too.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The drug and placebo were packed in envelopes labeled A and B so that neither the investigator nor the patient knew which one is drug or placebo until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Faculty of Medical Sciences, Azad University of Sari
Street address
Khazar Square- Farah Abad Blvd - 18th sea Road - University of the Holy Prophet of Azam- Faculty of Medicine- Department of Physiology and Pharmacology
City
sari
Province
Mazandaran
Postal code
4847191971
Approval date
2018-02-03, 1396/11/14
Ethics committee reference number
IR.IAU.SARI.REC.1396.50
Health conditions studied
1
Description of health condition studied
Pemphigus Vulgaris
ICD-10 code
L10.0
ICD-10 code description
Diseases of the skin and subcutaneous tissue
2
Description of health condition studied
Pemphigus foliaceus
ICD-10 code
L10.2
ICD-10 code description
Diseases of the skin and subcutaneous tissue
Primary outcomes
1
Description
IgG1: Measuring the amount of these factors in order to evaluate the role of metformin in the improvement of pemphigus.
Timepoint
Before the intervention (at the beginning of the study) and after the intervention (three months after receiving metformin)
Method of measurement
Immunological ELISA kits
2
Description
IgG4: Measuring the amount of these factors in order to evaluate the role of metformin in the improvement of pemphigus.
Timepoint
Before the intervention (at the beginning of the study) and after the intervention (three months after receiving metformin)
Method of measurement
Immunological ELISA kits
3
Description
NFkB: Measuring the amount of these factors in order to evaluate the role of metformin in the improvement of pemphigus
Timepoint
Before the intervention (at the beginning of the study) and after the intervention (three months after receiving metformin)
Method of measurement
Immunological ELISA kits
4
Description
TNFa: Measuring the amount of these factors in order to evaluate the role of metformin in the improvement of pemphigus
Timepoint
Before the intervention (at the beginning of the study) and after the intervention (three months after receiving metformin)
Method of measurement
Immunological ELISA kits
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Metformin HEXAL (Raha-Isfahan Pharmaceutical Company) receiving a dose of 2000 mg / day, divided into 1000 mg every 12 hours for three months.
Category
Treatment - Drugs
2
Description
Control group: Metformin placebo receptor at a dose of 2000 mg / day, divided in divided doses of 1000 mg every 12 hours, for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Gholamreza Houshmand
Street address
Department of Physiology and Pharmacology, Faculty of Medicine, Mazandaran University of Medical Sciences, Khazar Square, Khazar Blvd (18 km), Sari, Mazandaran, Iran
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Gholamreza Houshmand
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacology
Street address
Physiology and Pharmacology Department,, Faculty of Medicine, Mazandaran University of Medical Sciences, Khazar Square, Khazar Blvd (18 km), Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4847191971
Phone
+98 11 3354 3081
Email
g.houshmand@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Gholamreza Houshmand
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacology
Street address
Department of Physiology and Pharmacology,, Faculty of Medicine, Mazandaran University of Medical Sciences, Khazar Square, Khazar Blvd (18 km), Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4847191971
Phone
+98 11 3354 3081
Email
g.houshmand@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Gholamreza Houshmand
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacology
Street address
Department of Physiology and Pharmacology, Faculty of Medicine, Mazandaran University of Medical Sciences, Khazar Square, Khazar Blvd (18 km), Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4847191971
Phone
+98 11 3354 3081
Email
g.houshmand@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Qualitative variables such as age and sex, the decrease of symptoms and clinical manifestation of Pemphigus vulgaris and laboratory parameters: IgG1,4, TNFa, NFkB
When the data will become available and for how long
After the completion of the clinical trial and after the publication of the article
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
In order to study more widely and to help improve patients with pemphigus vulgaris
From where data/document is obtainable
Department of Physiology and Pharmacology, Faculty of Medicine, Mazandaran University of Medical Sciences, Khazar Square, Khazar Blvd (18 km), Sari, Mazandaran, Iran
What processes are involved for a request to access data/document
A written request should be sent to the respondent's email address, and if agreed, appointment time will be determined.