The effect of curcumin-piperine supplementation on inflammatory and metabolic factors in patients with rheumatoid arthritis: a double-blind clinical trial study
The effect of curcumin-piperine supplementation on inflammatory and metabolic factors in patients with rheumatoid arthritis
Design
This study is a clinical trial with a control and randomized parallel double-blind group, in which 60 patients with rheumatoid arthritis will be divided into two groups receiving curcumin-piperine supplement (n = 30) and placebo (n = 30).
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Willingness to participate in the study, age 20-65 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 year, lack of special diet and herbal supplements
Intervention groups
1) Intervention group (n = 30) daily one capsule containing curcumin piperine (containing 500 mg of curcumin extract and 5 mg of piperine 2) control group (n = 30) 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.
Main outcome variables
TC, TG, LDL, HDL (FBS) clinical signs, body inflammation index (hs-CRP) and ESR) and mean DASS score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121216011763N53
Registration date:2021-08-10, 1400/05/19
Registration timing:registered_while_recruiting
Last update:2021-08-10, 1400/05/19
Update count:1
Registration date
2021-08-10, 1400/05/19
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-24, 1400/05/02
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of curcumin-piperine supplementation on inflammatory and metabolic factors in patients with rheumatoid arthritis: a double-blind clinical trial study
Public title
Evaluation of the effect of curcumin-piperine in the treatment of rheumatoid arthritis
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Age: 20-65 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
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
ISFAHAN
Province
Isfehan
Postal code
8174673461
Approval date
2021-04-21, 1400/02/01
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.068
Health conditions studied
1
Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor
Primary outcomes
1
Description
Triglyceride
Timepoint
Beginning and end of the study
Method of measurement
Colorimetric analysis method and by autoanalyzer
2
Description
Cholesterol
Timepoint
Beginning and end of the study
Method of measurement
Colorimetric analysis method and by autoanalyzer
3
Description
High-density lipoprotein (HDL)
Timepoint
Beginning and end of the study
Method of measurement
Colorimetric analysis method and by autoanalyzer
4
Description
Low density lipoprotein (LDL)
Timepoint
Beginning and end of the study
Method of measurement
Colorimetric analysis method and by autoanalyzer
5
Description
Fasting blood sugar
Timepoint
Beginning and end of the study
Method of measurement
Colorimetric analysis method and by autoanalyzer
6
Description
C-reactive protein (CRP)
Timepoint
Beginning and end of the study
Method of measurement
Colorimetric analysis method and by autoanalyzer
7
Description
ESR
Timepoint
Beginning and end of the study
Method of measurement
Enzymatic method
8
Description
DAS
Timepoint
Beginning and end of the study
Method of measurement
DASS questionnaire
9
Description
Clinical signs
Timepoint
Beginning and end of the study
Method of measurement
Diagnosis by a specialist
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Ghulam Reza Askari
Street address
Sofe Boulevard
City
ISFAHAN
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
askari@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjou
Street address
Hezar Jarib
City
ISFAHAN
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave
City
ISFAHAN
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 1378
Email
askari@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave
City
ISFAHAN
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
Email
askari@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
Email
askari@mui.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
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The collected deidentified for the primary outcome measure only will be shared.
When the data will become available and for how long
12 months after publication
To whom data/document is available
Available for people working in academic institutions
Under which criteria data/document could be used
To conduct similar studies
From where data/document is obtainable
askari@mui.ac.ir
What processes are involved for a request to access data/document
The data will send as soon as possible, after receiving the request.