Protocol summary

Study aim
Determining the effect of curcumin supplementation on clinical symptoms, inflammatory factors, oxidative stress biomarkers in Rheumatoid arthritis patients
Design
In this clinical trial (phase 3), two parallel, two-blind, randomized groups with two groups as Control and Intervention (30 people in each group) were first selected as available and then randomly selected in each group. They are selected based on body mass index and weight
Settings and conduct
This study was conducted in Rheumatoid arthritis patients referred to the Rheumatology clinic of Shahid Beheshti Hospital in Kashan. In this study, patients in both Intervention and Control groups receive standard treatment. In the intervention group, Curcumin produced by Dinah Pharmaceutical Company, with a dose of 500 mg, 1 tablet daily for 12 weeks, in addition to standard treatment and in the control group Placebo is used in addition to standard treatment. Placebo and Curcumin are both in the same form, same weight and same packaging, which is written by the researcher on the back of the package, and the doctor and the patient do not know whether it is a drug or a placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Rheumatoid arthritis based on diagnostic criteria Age 20-70 years No smoking. Exclusion criteria: Reluctance to cooperate Hypothyroidism or hyperthyroidism Consumption of any type of supplement (Vitamins, salts, etc.) by the patient during the last 3 months Having any acute and active infection.
Intervention groups
Intervention group: Taking Curcumin alongside standard treatment Control group: receiving a Placebo alongside the standard treatment
Main outcome variables
Severity of clinical symptoms before and after treatment based on Disease Activity Score 28 and Visual Analog Scale; plasma total antioxidant; plasma malondialdehyde; serum Hs-CRP

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101014004934N3
Registration date: 2023-11-27, 1402/09/06
Registration timing: registered_while_recruiting

Last update: 2023-11-27, 1402/09/06
Update count: 0
Registration date
2023-11-27, 1402/09/06
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
5550030-0361
Email address
kamalesalatmanesh@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of curcumin supplementation on clinical status, inflammatory factors, oxidative stress biomarkers in patients with rheumatoid arthritis
Public title
Investigating the effect of curcumin in rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with rheumatoid arthritis based on diagnostic criteria Age 20-70 years No smoking
Exclusion criteria:
Reluctance to cooperate Hypothyroidism or hyperthyroidism Consumption of any type of supplement (vitamins, salts, etc.) by the patient during the last 3 months Having any acute and active infection
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, initial sampling is done by the 'available' method from the rheumatology clinic of Beheshti Hospital among the patients who come for treatment. The way of randomization is that rheumatoid arthritis patients are placed in separate classes based on two criteria: BMI (BMI < 30 and BMI ≥ 30) and age (> 45 and ≤ 45) and then are randomly assigned to one of the two groups. Curcumin or placebo (containing starch) are added as supplements. Randomization is done using Stat Trek software and based on the random number table method.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the attending physician are not aware of the fact that the patient is receiving a placebo or curcumin supplement.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Shahid Beheshti Hospital, Hekmat 56 ave, Qutb Rawandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973447
Approval date
2023-10-22, 1402/07/30
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1402.180

Health conditions studied

1

Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified

Primary outcomes

1

Description
Severity of clinical symptoms before and after treatment
Timepoint
Before the start of the intervention and twelve weeks later
Method of measurement
Based on Disease Activity Score 28 (DAS28) and Visual Analog Scale (VAS)

2

Description
Total plasma antioxidant
Timepoint
Before the start of the intervention and twelve weeks later
Method of measurement
Antioxidant capacity of plasma is determined by ELISA method

3

Description
Plasma malondialdehyde
Timepoint
Before the start of the intervention and twelve weeks later
Method of measurement
Determination of malondialdehyde is done by ELISA method

4

Description
Serum Hs-CRP
Timepoint
Before the start of the intervention and twelve weeks later
Method of measurement
Serum hs-CRP is performed using an ELISA device (immunoassay method).

Secondary outcomes

empty

Intervention groups

1

Description
The Intervention group: includes 30 Rheumatoid arthritis patients aged 20 to 70 referring to the Rheumatology clinic of Shahid Beheshti Hospital in Kashan (out of 60 Rheumatoid arthritis patients randomly selected), who are supplemented with Curcumin produced by Dineh Pharmaceutical Company, with a dose of 500 mg, 1 daily for 12 weeks in addition to the standard treatment of Rheumatoid arthritis.
Category
Treatment - Drugs

2

Description
Control group: includes 30 Rheumatoid arthritis patients aged 20 to 70 referring to the Rheumatology clinic of Shahid Beheshti Hospital in Kashan (out of sixty Rheumatoid arthritis patients randomly selected), who received a Placebo pill (Starch: containing 505 mg of Maltodextrin) with the appearance characteristics Same as 505 mg Curcumin supplement, 1 daily for 12 weeks in addition to standard treatment of Rheumatoid arthritis.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Rheumatology Clinic of Shahid Beheshti Hospital, Kashan
Full name of responsible person
Kamal Esalatmanesh
Street address
Shahid Beheshti Hospital, Hekmat 56 ave, Qutb Rawandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973447
Phone
+98 31 5500 9999
Email
beheshtihospital@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi
Street address
Research Vice-Chancellor, Kashan University of Medical Sciences, 5th kilometer of Qutb Rawandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9399
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Kamal Esalatmanesh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Beheshti Hospital, Hekmat 56 ave, Qutb Rawandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973447
Phone
+98 31 5500 9999
Email
Kamalesalatmanesh@kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Kamal Esalatmanesh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Beheshti Hospital, Hekmat 56 ave, Qutb Rawandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973447
Phone
+98 31 5500 9999
Email
Kamalesalatmanesh@kaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Kamal Esalatmanesh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Beheshti Hospital, Hekmat 56 ave, Qutb Rawandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973447
Phone
+98 31 5500 9999
Email
Kamalesalatmanesh@kaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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