The effect of curcumin-piperine supplementation on anthropometric indices and clinical signs in patients with rheumatoid arthritis A double-blind clinical trial study
The effect of curcumin-piperine supplementation on anthropometric indices and clinical signs in patients with rheumatoid arthritis
Design
This trial is a randomized double blinded study. Randomization is done by Excel software on 60 patients.
Settings and conduct
This double-blind study was performed on patients with rheumatoid arthritis referred to Al-Zahra Hospital clinic. The intervention group received curcumin-piperine supplement for 12 weeks and the control group received maltodextrin supplement for 12 weeks. In this study, blindness is performed on researchers and patients who participated in the project
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Age 20-60 years
Rheumatoid arthritis according to the rheumatologist according to the American College of Rheumatology 2010, the disease activity score is higher than 1.5 and the total soft joint count (TJC) and swollen joint count (SJC) is higher than 8 (32).
Inclusion 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.
Intervention groups
Group 1) Patients who receive one placebo capsule daily for 12 weeks, each capsule containing 500 mg of maltodextrin per day. (30 patients) Group 2) Patients who receive one 500 mg capsule per day containing 500 mg curcumin and 5 mg piperine daily for 12 weeks (30 patients)
Main outcome variables
Clinical signs in patients with rheumatoid arthritis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120701010149N3
Registration date:2021-05-01, 1400/02/11
Registration timing:prospective
Last update:2021-05-01, 1400/02/11
Update count:0
Registration date
2021-05-01, 1400/02/11
Registrant information
Name
peyman mottaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3229 3863
Email address
motaghi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-04, 1400/02/14
Expected recruitment end date
2022-05-04, 1401/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of curcumin-piperine supplementation on anthropometric indices and clinical signs in patients with rheumatoid arthritis A double-blind clinical trial study
Public title
The effect of curcumin on rheumatoid arthritis
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Age 20-60 years
Rheumatoid arthritis according to the rheumatologist according to the American College of Rheumatology 2010, the disease activity score is higher than 1/5 and the total soft joint count (TJC) and swollen joint count (SJC) is higher than 8.
Exclusion criteria:
Pregnancy and lactation
Smoking
Heart, lung and kidney disease, hepatitis, cirrhosis, biliary and immune system disorders, hypertension, diabetes, hypothyroidism, Cushing's syndrome
Age
From 20 years old to 60 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
They will be randomly divided into one of two groups of intervention and placebo and will be studied for 12 weeks. The intervention group will receive a daily capsule containing curcumin piperine (containing 500 mg of curcumin extract and 5 mg of piperine) and the control group will receive a daily placebo capsule (500 mg of maltodextrin) with diet and exercise recommendations; The recommendations are the same in both groups.
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 track that individuals in the study groups use the capsules
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Azadi Square, Hezar Jarib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Approval date
2021-01-24, 1399/11/05
Ethics committee reference number
IR.MUI.MED.REC.1399.975
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
Symptoms
Timepoint
Beginning and end of the study
Method of measurement
Symptoms will be measured using the Disease Activity Score of 28 joints (DAS ‐ 28). Soft joint count (TJC) and swollen joint count (SJC) are determined by a rheumatologist.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients receiving one 500 mg capsule per day of curcumin-piperine (500 mg curcumin-5 mg piperine) per day for 12 weeks (30 patients)
Category
Treatment - Drugs
2
Description
Control group: Patients receiving 1 placebo capsule containing 500 mg maltodextrin daily for 12 weeks (30 patients)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
peiman motaghi
Street address
Azadi Square, Hezar Jarib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3620 2020
Email
motaghi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
Isfahan-Hezar Jarib Boulevard
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3222 2127
Email
mtav9614@gmail.com
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
peiman motaghi
Position
دانشیار
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Azadi Square, Hezar Jarib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3620 2020
Email
motaghi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
پیمان متقی
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Azadi Square, Hezar Jarib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3620 2020
Email
motaghi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
peiman motaghi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Azadi Square, Hezar Jarib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3620 2020
Email
motaghi@med.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
Not applicable
Title and more details about the data/document
All data can be shared at the request of individuals
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
By sending an email to the following address that belongs to the executor of the project: motaghi@med.mui.ac.ir
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.