Efficacy evaluation of oral formulation of Bene extract in treatment of moderate to severe rheumatoid arthritis and its effect on serum level of inflammatory cytokines TNF-α and IL-1
Efficacy evaluation of oral formulation of Bene extract in treatment of moderate to severe rheumatoid arthritis and its effect on serum level of inflammatory cytokines TNF-α and IL-1
Design
Using a systematic random method, a number of patients will be selected as research units. In the next stage, these people will be assigned to two groups of intervention and placebo using four permutation blocks
Settings and conduct
patients referred to Allameh Behlool Gonabadi Hospital, in whom the diagnosis of rheumatoid arthritis has been proven according to the aforementioned criteria, will be prepared. This study is three-way, so The researcher, subject and statistical analyst are unaware of the status of allocation of the two groups to the study.In this study, the subject is not aware of the status of allocation to groups.
Participants/Inclusion and exclusion criteria
- Inclusion criteria:
- Age between 18 to 65 years
- Score 6 out of ten ACR / EULAR 2010 criteria
Moderate-severe disease severity according to SDAI criteria (above 11)
- Filling in the written consent
Inclusion criteria
- Diabetes and other inflammatory and autoimmune diseases
- Heart failure, liver and kidney
Pregnancy or breastfeeding
Intervention groups
The intervention group will receive 2 capsules of coriander extract containing luteolin (equivalent to 75 mg) daily for 3 months and the control group will receive 2 placebo capsules daily.
Main outcome variables
evaluation of disease severity based on DSAI at the beginning of study and after 3m
evaluation of serum level of CRP, ESR, IL-1, TNF-a, LFT at the beginning and after 3 m
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201101049223N1
Registration date:2020-12-21, 1399/10/01
Registration timing:registered_while_recruiting
Last update:2020-12-21, 1399/10/01
Update count:0
Registration date
2020-12-21, 1399/10/01
Registrant information
Name
Davoud Salarbashi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 5027
Email address
davoud.salarbashi3@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy evaluation of oral formulation of Bene extract in treatment of moderate to severe rheumatoid arthritis and its effect on serum level of inflammatory cytokines TNF-α and IL-1
Public title
Efficacy evaluation of oral formulation of Bene extract in treatment of moderate to severe rheumatoid arthritis and its effect on serum level of inflammatory cytokines TNF-α and IL-1
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 65 years
Score 6 out of ten ACR / EULAR 2010
criteriaModerate-severe disease according to SDAI criteria (above 11)
Patients who continue to have joint pain and swelling despite receiving standard medications (methotrexate, hydroxychloroquine, sulfasalazine, and prednisolone).
The type of drug and its dose should be constant for at least 1 month before the study and remain the same during the study.
Filling in the written consent
Exclusion criteria:
pregnancy and lactation
diabetes melitus
HF with EF<40%
severe infection need IV antibiotics
smoking more than 10 cigarette per day
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
134
Randomization (investigator's opinion)
Randomized
Randomization description
By use of a randomization list provided by randomization.com site, boxes of medication or placebo will be numbered from 1 to 134. Then patients will receive boxes respectively.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The Bene capsule and placebo tablets will be packaged in identical-looking bottle and delivered to the clinician. Patients who meet the inclusion criteria are selected by clinician to be included in the study, randomly assigned to a drug or placebo group and given a bottle with A or B mark. Patients will be evaluated in the course of treatment by the physician and the medical student. Data collection and analysis are performed by the medical student and the clinical pharmacist. All of them will be unaware that A or B is on medication or placebo until the end of the study and data analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Asian Roadside - Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2020-10-26, 1399/08/05
Ethics committee reference number
IR.GMU.REC.1399.086
Health conditions studied
1
Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M05
ICD-10 code description
Seropositive rheumatoid arthritis
Primary outcomes
1
Description
Laboratory response
Timepoint
At the beginning of the study and 3 months later
Method of measurement
based on simplified disease activity index (SDAI)
2
Description
Clinical response to treatment (improved function of joints and morning dryness)
Timepoint
At the beginning of the study and 3 months later
Method of measurement
Based on patient interview and clinical examination
3
Description
serum level of ESR, CRP, IL-1, TNF-a
Timepoint
At the beginning of the study and 3 months later
Method of measurement
laboratory exam
Secondary outcomes
1
Description
Finally the patient is clinically
Timepoint
End of treatment
Method of measurement
Clinical examination and laboratory results
Intervention groups
1
Description
Intervention group: For 3 months, receive 2 capsules per day of Baneh extract containing 75 mg of luteolin which will be prepared by Mashhad School of Pharmacy.
Category
Treatment - Drugs
2
Description
Control group: On a daily basis, they will receive two placebo capsules with the same appearance as the drug capsule and containing all the exponents inside the drug capsule except the Baneh extract and will be prepared by Mashhad School of Pharmacy.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bohlool hospital
Full name of responsible person
Farhang Soltani
Street address
Vahdat Ave , Bohlool hospital
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6833
Email
bohlool@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Shahla Khosrowan
Street address
Asian Roadside - Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
74
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
2
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Davoud Salarbashi
Street address
Asian Roadside - Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Email
davoud.salarbashi3@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research grant of Dr. Davoud Salarbashi
Proportion provided by this source
27
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
Gonabad University of Medical Sciences
Full name of responsible person
Davoud Salarbashi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Asian Roadside - Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Email
davoud.salarbashi3@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sepideh Elyasi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Azadi Square, University Campus, Faculty of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1588
Email
Elyasis@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Milad Iranshahi
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Azadi Square, University Campus, Faculty of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1100
Email
IranshahiML@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
The results of the study will be published in the form of an article. The study protocol and statistical analysis used in the article will be considered.
When the data will become available and for how long
The information will be published one year after the study and will be available in the sources
To whom data/document is available
Information will be available to academic researchers, physicians and academic institutions with the permission of the sponsor.
Under which criteria data/document could be used
Other researchers can use the results of the study in their review and meta-analysis
From where data/document is obtainable
For this purpose, you can request Sepideh Eliassy with the following information.
Mashhad, Vakilabad Blvd, School of Pharmacy,Department of Clinical Pharmacy
What processes are involved for a request to access data/document
Upon receipt of the application, the scientific officer of the study will respond to the applicant within two weeks, depending on the type of information requested, after coordination with the sponsor.