In this study we aim to evaluate the efficacy of suranjefel in clinical manifestation and laboratory parameters in patients with active rheumatoid arthritis in intervention group compared with placebo . in this study we also evaluate and analyze safety and adverse reaction of this drug.
Design
a phase 3 , randomized , double-blinded clinical trial in two parallel groups . 88 patients are entered in this study . blocking method with dice is used for randomizing .
Settings and conduct
In this study 88 patients with active rheumatoid arthritis based on inclusion and exclusion criteria referred from shahid beheshti hospital will be admitted . patients will randomly divided to control and intervention group and take drug and placebo twice a day for three month in parallel (each pill contains 125 milligram of substance ) . DAS28 questionnaire and ACR20/50/70 criteria are assessed monthly and interlukin6 and other blood tests are performed at the beginning and at the end of study and then are analyzed at the end . this study is performing blindly and the patient , physician and researcher do not know wheter the patient is receiving mediv=cation or placebo.
Participants/Inclusion and exclusion criteria
patients with active rheumatoid arthritis who are between 18-65 years old and were diagnosed more than 3 month ago and are not pregnant ore breastfeeding and do not suffer from serious medical condition like diabetes mellitus , cardiovascular disease and severe hepatic or renal disfunction .
Intervention groups
intervention group : the group of patients who take the pill twice a day for three month
control group : the group with same condition who take the placebo
Main outcome variables
clinical manifestation based on DAS28 questionnaire ؛ improving symptoms based on ACR 20/50/70 criteria ؛ interlukin6
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211214053400N1
Registration date:2021-12-26, 1400/10/05
Registration timing:registered_while_recruiting
Last update:2021-12-26, 1400/10/05
Update count:0
Registration date
2021-12-26, 1400/10/05
Registrant information
Name
Farzane Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2209 0351
Email address
heidariifarzane@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-20, 1400/09/29
Expected recruitment end date
2022-06-19, 1401/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of efficacy and safety of suranjafel in patients with rheumatoid arthritis
Public title
Study of efficacy and safety of suranjafel in patients with rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with active rheumatoid arthritis
patients who are diagnosed more than 3 months ago
patients with BMI less than 40
Exclusion criteria:
chronic diseases like diabetes mellitus , cardiovascular disease and severe hepatic or renal disfunction
patients who got drug reaction
pregnancy and breastfeeding
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization. We will have 4 blocks of 6 and the selection of each block will be random and we use dice each time.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study participants, physicians and researchers are not aware whether they get drug or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qum University of Medical Sciences
Street address
Qum University of Medical Science , Shahid Lavasani Street , Qum
City
Qum
Province
Ghoum
Postal code
3713649373
Approval date
2021-10-26, 1400/08/04
Ethics committee reference number
IR.MUQ.REC.1400.144
Health conditions studied
1
Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified
Primary outcomes
1
Description
Clinical activity of disease based on disease activity score 28 questionnaire (DAS28)
Timepoint
At the beginning of the study and then one month , two month and three month later
Method of measurement
Disease activity score 28 questionnaire (DAS28)
2
Description
Measure of improvement of patient clinical manifestation based on ACR regular 2010 criteria
Timepoint
At the beginning of the study and then one month , two month and three month later
Method of measurement
ACR regular 2010 criteria
3
Description
The level of interlukin6
Timepoint
At the beginning and the three month later at the end of study
Method of measurement
Blood test
Secondary outcomes
1
Description
The level of erythrocyte sedimentation rate
Timepoint
At the beginning and then at the end of syudy
Method of measurement
Blood test
2
Description
The level of c-reactive protein
Timepoint
At the beginning and then at the end of syudy
Method of measurement
Blood test
3
Description
The level of Rheumatoid Factor
Timepoint
At the beginning and then at the end of syudy
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group:
Category
Treatment - Drugs
2
Description
Control group:
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Farzane Heidari
Street address
Shahid beheshti Blvd , Qum
City
qum
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Fax
Email
bmc@muq.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Ehsan sharifipour
Street address
Shahid Lavasani street , Qum
City
Qum
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3107 1111
Email
bmc@muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
bouali Pharmaceutical Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Farzane Heidari
Position
medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahid beheshti Blvd
City
Qum
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
heidariifarzane@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Farzane Heidari
Position
medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
shahid beheshti hospital, Shahid beheshti Blvd.
City
Qum
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
heidariifarzane@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
farzane heidari
Position
medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahid beheshti Blvd.
City
Qum
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
heidariifarzane@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available