Determining the Effect of Propolis Supplementation on Inflammatory Factors and Oxidative Status in Women with Rheumatoid Arthritis
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 48 patients. The rand function of the Excel software was used for randomization.
Settings and conduct
This study will be held at Emam Reza Hospital. The sample size is 48 and subjects will be distributed in each of 2 groups randomly. Participants and investigators are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People in the age range of 20-70 years; Patients with moderate and severe disease activity score 28; Do not take antioxidant supplements for at least 1 month before starting the study; The tendency to cooperate and sign informed written consent; Diagnosis of the disease by a rheumatologist based on the criteria of the american college of rheumatology Exclusion criteria: Pregnancy and lactation; Taking oral contraceptive pills; History of chronic diseases such as diabetes mellitus, kidney failure, liver failure and cancer; Having other autoimmune and inflammatory diseases; Having hormonal disorders, Thyroid disorders; Alcohol consumption and hookah; Use smoking and being exposed to secondhand smoke
Intervention groups
In this study participants will distribute in 2 groups and each group has 24 individuals. Intervention group: Supplement propolis. Placebo group: Intake of placebo supplement.
Main outcome variables
Assessing the total antioxidant capacity level; Total oxidative status; Alpha tumor necrosis factor; Interleukin 17; Malondialdehyde; Glutathione peroxidase; Superoxide dismutase
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190407043194N2
Registration date:2020-07-22, 1399/05/01
Registration timing:prospective
Last update:2020-07-22, 1399/05/01
Update count:2
Registration date
2020-07-22, 1399/05/01
Registrant information
Name
Maryam khosravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2103
Email address
khosravim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-05, 1399/05/15
Expected recruitment end date
2021-03-05, 1399/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the Effect of Propolis Supplementation on Inflammatory Factors and Oxidative Status in Women with Rheumatoid Arthritis
Public title
Evaluation the effect of propolis on rheumatoid arthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People in the age range of 20-70 years
Patients with moderate and severe disease activity score 28
Do not take antioxidant supplements for at least 1 month before starting the study
The tendency to cooperate and sign informed written consent
Diagnosis of the disease by a rheumatologist based on the criteria of the American College of Rheumatology
Exclusion criteria:
Pregnancy and lactation
Taking oral contraceptive pills
History of chronic diseases such as diabetes mellitus, kidney failure, liver failure and cancer
Having other autoimmune and inflammatory diseases
Having Hormonal disorders, thyroid disorders
Alcohol consumption and hookah smoke
Smoking and being exposed to secondhand smoke
Age
From 20 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will allocate in each group by:
Allocation will randomize in blocks of size 4 (two placebos,two propolis) will design by RAS software. Each block will stratify by patient's baseline characteristics of body mass index (less or more than 30 kg/m²), Severity of disease (moderate or sever) and menstrual status (yes or no).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study investigator and participants are blind from groups and how they are randomized
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Nutrition Department, Medicine School, Mashhad University of Medical Sciences, University campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2020-07-05, 1399/04/15
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.145
Health conditions studied
1
Description of health condition studied
Arthritis rheumatoid
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified
Primary outcomes
1
Description
Total antioxidant capacity
Timepoint
Before and after of intervention
Method of measurement
Elisa kit
2
Description
Interleukin 17
Timepoint
Before and after of intervention
Method of measurement
Elisa kit
3
Description
Total oxidant status
Timepoint
Before and after of intervention
Method of measurement
Elisa kit
4
Description
Tumor necrosis factor alpha
Timepoint
Before and after of intervention
Method of measurement
Elisa kit
5
Description
Malondialdehyde
Timepoint
Before and after of intervention
Method of measurement
Elisa kit
6
Description
Glutathione peroxidase
Timepoint
Before and after of intervention
Method of measurement
Elisa kit
7
Description
Catalase
Timepoint
Before and after of intervention
Method of measurement
Elisa kit
8
Description
Superoxide dismutase
Timepoint
Before and after of intervention
Method of measurement
Elisa kit
9
Description
Triglyceride
Timepoint
Before and after of intervention
Method of measurement
Laboratory test
10
Description
Low density lipoprotein
Timepoint
Before and after of intervention
Method of measurement
Laboratory test
11
Description
High density lipoprotein
Timepoint
Before and after of intervention
Method of measurement
Laboratory test
12
Description
Blood pressure
Timepoint
Before and after of intervention
Method of measurement
Mercury barometer
13
Description
Dietary intake
Timepoint
Before and after of intervention
Method of measurement
Three days food record
14
Description
Physical activity
Timepoint
Before and after of intervention
Method of measurement
International Physical Activity Questionnaire
15
Description
Anthropometric measurements
Timepoint
Before and after of intervention
Method of measurement
Body mass index, waist circumference, Hip circumference
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Propolis supplement (Propolis supplement capsule containing 500 mg of propolis, Shahdineh Golha Pharmaceutical Company, 2 times a day, daily consumption for 3 months, with water).
Category
Prevention
2
Description
Control group: Placebo (placebo capsule containing 500 mg of wheat starch, Shahdineh Golha Pharmaceutical Company, 2 times a day, daily consumption for 3 months, with water).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Maryam Khosravi
Street address
Imam Reza Hospital, Chamran Ave, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2367
Email
KhosraviM@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeid Eslami
Street address
Mashhad University of Medical Sciences, University campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2420
Email
Eslamis@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
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
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Khosravi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, medicine School, Mashhad University of Medical Sciences, Univesity campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2367
Email
Khosravim@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Khosravi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, medicine School, Mashhad University of Medical Sciences, Univesity campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2367
Email
khosravim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Khosravi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Medicine School, Mashhad University of Medical Sciences, University campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2420
Email
khosravim@mums.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
No - There is not 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
Primary outcomes will be share.
When the data will become available and for how long
Starting 6 month after publication
To whom data/document is available
Researchers
Under which criteria data/document could be used
For Metanalysis
From where data/document is obtainable
Making contact with Dr. Mariam Khosravi
What processes are involved for a request to access data/document
Making contact with Dr. Mariam Khosravi and asking for the data, if she approved, request will be send to university president, if they approved the data will send for applicant.