Protocol summary
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Study aim
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The effect of curcumin-piperine supplementation on inflammatory factors and clinical signs in patients with rheumatoid arthritis
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Design
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This study is a clinical trial with a control and randomized parallel double-blind group, in which 50 patients with rheumatoid arthritis will be divided into two groups receiving curcumin-piperine supplement (n = 25) and placebo (n = 25).
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Settings and conduct
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In this study, people with rheumatoid arthritis will be admitted to Al-Zahra Hospital. Random allocation will be done using a random number table. Entry of individuals and assignment of each person to one of the two groups will be done by the relevant specialist. Curcumin-piperine supplement and placebo will be packaged in similar boxes and the researcher and patients will not be informed of the contents of the packages until the end of the study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Willingness to participate in the study, age 30-70 years, completing informed consent.Rheumatoid arthritis According to the rheumatologist
Inclusion criteria:
Pregnancy and lactation Smoking
Underlying diseases, weight loss and bariatric surgery in a recent years, lack of special diet and herbal supplements
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Intervention groups
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1) Intervention group (n = 25) daily one capsule containing curcumin piperine (containing 500 mg of curcumin extract and 5 mg of piperine 2) control group (n = 25) daily placebo capsule (500 mg of maltodextrin) with diet and activity recommendations They will receive a body; patients will be given a supplement can for one month to evaluate the use of supplements. The patient must return the supplement can monthly and specify the number inside.
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Main outcome variables
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Clinical signs, inflammation indices such as quantitative CRP and ESR, and oxidative stress factors such as TAC and TOS
General information
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Reason for update
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Age change of the participants and some outcomes of the study
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20121216011763N53
Registration date:
2021-08-10, 1400/05/19
Registration timing:
prospective
Last update:
2022-08-18, 1401/05/27
Update count:
1
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Registration date
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2021-08-10, 1400/05/19
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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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2021-12-22, 1400/10/01
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Expected recruitment end date
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2022-08-22, 1401/05/31
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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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The effect of curcumin-piperine supplementation on inflammatory factors and clinical signs in patients with rheumatoid arthritis: a double-blind clinical trial study
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Public title
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Evaluation of the effect of curcumin-piperine in the treatment of rheumatoid arthritis
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Purpose
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Basic scienece
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Inclusion/Exclusion criteria
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Inclusion criteria:
Willingness to participate in the study
Age: 30-70 years
Complete informed consent
Rheumatoid arthritis according to the rheumatologist according to the criteria of the American College of Rheumatology 2010
Disease activity score higher than 1/5 and total soft joint count (TJC) and swollen joint count (SJC) higher than 8
Exclusion criteria:
Pregnancy and lactation
Smoking
Heart, lung, kidney, hepatitis, cirrhosis, biliary and immune system disorders, hypertension, diabetes, hypothyroidism, Cushing's syndrome
Weight loss and bariatric surgery in the last year.
Lack of following a special diet and herbal supplements
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Age
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From 30 years old to 70 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
50
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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 be divided into intervention and control groups using block classified randomization. The following authoritative site will be used to allocate the intervention in the above-mentioned manner.
https://www.sealedenvelope.com/simple-randomiser/v1/lists
In this way, people are randomly divided into two groups of intervention and control using quadruple blocks based on age and sex.
It is noteworthy that participants and outcome assessors will not be aware of patient grouping and will be blind to it.
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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 order to conduct this research in a double-blind manner, before starting the study, the total capsules are coded in A and B by a person other than the researcher, so that both groups do not know the type of capsules received by both groups. To keep track of people in the study groups using the capsules, they will be contacted weekly by phone or text message and will be reminded of the capsule use. To check patients' compliance, curcumin and placebo capsules are given to them on a monthly basis and they are asked to deliver the previous capsule pack so that we can give them the new pack. Capsule use is also reminded and evaluated by weekly phone calls and text messages.
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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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2021-04-21, 1400/02/01
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1400.068
Health conditions studied
1
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Description of health condition studied
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Rheumatoid Arthritis
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ICD-10 code
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M05
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ICD-10 code description
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Rheumatoid arthritis with rheumatoid factor
Primary outcomes
1
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Description
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Total antioxidant capacity (TAC)
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Timepoint
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Beginning and end of the study
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Method of measurement
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Elisa
2
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Description
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Total Oxidant Status (TOS)
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Timepoint
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Beginning and end of the study
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Method of measurement
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Elisa
3
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Description
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C-reactive protein (CRP)
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Timepoint
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Beginning and end of the study
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Method of measurement
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Colorimetric analysis method and by autoanalyzer
4
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Description
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ESR
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Timepoint
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Beginning and end of the study
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Method of measurement
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Enzymatic method
5
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Description
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Clinical signs
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Timepoint
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Beginning and end of the study
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Method of measurement
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Diagnosis by a specialist
Intervention groups
1
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Description
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Intervention group: Take one capsule containing curcumin piperine daily (containing 500 mg curcumin extract and 5 mg piperine) for 12 weeks. They will also receive diet and exercise advice.Dietary recommendations mainly include emphasizing the consumption of foods containing antioxidants in order to reduce inflammation and prevent the increase of inflammation, such as the cabbage and berry family. It is also recommended that people do a little physical activity that does not increase the problems caused by rheumatoid arthritis and help improve the condition.
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Category
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Treatment - Drugs
2
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Description
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Control group: They will receive one placebo capsule (500 mg of maltodextrin) daily with diet and exercise recommendations. Dietary recommendations mainly include emphasizing the consumption of foods containing antioxidants in order to reduce inflammation and prevent the increase of inflammation, such as the cabbage and berry family. It is also recommended that people do a little physical activity that does not increase the problems caused by rheumatoid arthritis and help improve the condition.
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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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Esfahan 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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Yes - There is 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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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The collected deidentified for the primary outcome measure only will be shared.
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When the data will become available and for how long
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12 months after publication
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To whom data/document is available
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Available for people working in academic institutions
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Under which criteria data/document could be used
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To conduct similar studies
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From where data/document is obtainable
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askari@mui.ac.ir
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What processes are involved for a request to access data/document
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The data will send as soon as possible, after receiving the request.
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Comments
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