Protocol summary
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Study aim
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Determining the Effect of Propolis Supplementation on Inflammatory Factors and Oxidative Status in Women with Rheumatoid Arthritis
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Assessing the total antioxidant capacity level; Total oxidative status; Alpha tumor necrosis factor; Interleukin 17; Malondialdehyde; Glutathione peroxidase; Superoxide dismutase
General information
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Reason for update
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The start date of the intervention was postponed due to lack of supplements.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190407043194N2
Registration date:
2020-07-22, 1399/05/01
Registration timing:
prospective
Last update:
2022-06-03, 1401/03/13
Update count:
2
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Registration date
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2020-07-22, 1399/05/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-08-06, 1400/05/15
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Expected recruitment end date
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2022-03-06, 1400/12/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Determining the Effect of Propolis Supplementation on Inflammatory Factors and Oxidative Status in Women with Rheumatoid Arthritis
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Public title
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Evaluation the effect of propolis on rheumatoid arthritis
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 70 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
48
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study investigator and participants are blind from groups and how they are randomized
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-07-05, 1399/04/15
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1399.145
Health conditions studied
1
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Description of health condition studied
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Arthritis rheumatoid
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ICD-10 code
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M06.9
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ICD-10 code description
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Rheumatoid arthritis, unspecified
Primary outcomes
1
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Description
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Total antioxidant capacity
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Timepoint
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Before and after of intervention
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Method of measurement
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Elisa kit
2
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Description
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Interleukin 17
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Timepoint
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Before and after of intervention
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Method of measurement
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Elisa kit
3
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Description
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Total oxidant status
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Timepoint
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Before and after of intervention
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Method of measurement
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Elisa kit
4
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Description
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Tumor necrosis factor alpha
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Timepoint
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Before and after of intervention
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Method of measurement
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Elisa kit
5
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Description
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Malondialdehyde
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Timepoint
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Before and after of intervention
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Method of measurement
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Elisa kit
6
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Description
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Glutathione peroxidase
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Timepoint
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Before and after of intervention
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Method of measurement
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Elisa kit
7
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Description
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Catalase
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Timepoint
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Before and after of intervention
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Method of measurement
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Elisa kit
8
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Description
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Superoxide dismutase
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Timepoint
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Before and after of intervention
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Method of measurement
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Elisa kit
9
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Description
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Triglyceride
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Timepoint
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Before and after of intervention
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Method of measurement
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Laboratory test
10
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Description
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Low density lipoprotein
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Timepoint
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Before and after of intervention
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Method of measurement
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Laboratory test
11
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Description
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High density lipoprotein
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Timepoint
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Before and after of intervention
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Method of measurement
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Laboratory test
12
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Description
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Blood pressure
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Timepoint
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Before and after of intervention
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Method of measurement
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Mercury barometer
13
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Description
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Dietary intake
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Timepoint
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Before and after of intervention
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Method of measurement
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Three days food record
14
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Description
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Physical activity
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Timepoint
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Before and after of intervention
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Method of measurement
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International Physical Activity Questionnaire
15
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Description
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Anthropometric measurements
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Timepoint
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Before and after of intervention
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Method of measurement
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Body mass index, waist circumference, Hip circumference
16
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Description
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High sensivity C-reactive protein
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Timepoint
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Before and after of intervention
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Method of measurement
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Elisa kit
17
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Description
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Monocyte Chemoattractant Protein-1
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Timepoint
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Before and after of intervention
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Method of measurement
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Elisa kit
18
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Description
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Nitric oxide
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Timepoint
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Before and after of intervention
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Method of measurement
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Elisa kit
Intervention groups
1
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Description
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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).
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Category
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Prevention
2
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Description
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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).
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Primary outcomes will be share.
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When the data will become available and for how long
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Starting 6 month after publication
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To whom data/document is available
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Researchers
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Under which criteria data/document could be used
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For Metanalysis
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From where data/document is obtainable
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Making contact with Dr. Mariam Khosravi
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What processes are involved for a request to access data/document
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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.
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Comments
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