Protocol summary

Summary
The aim of this study was to evaluate the effect of anti-inflammatory capsules containing three of ginger, turmeric and black pepper in patients with active rheumatoid arthritis.The assumption is appropriate in the event of proven effectiveness of this drug in the treatment of rheumatoid arthritis is helping to accelerate and also due to the numerous complications of corticosteroids may be that these drugs are corticosteroids or it can be replaced in the future as far as possible to reduce the dosage of corticosteroids in these patients.The study is double-blind. All patients enrolled in this study, people over 18 years old and suffering rheumatoid arthritis based on ACR 2010 criteria by expert rheumatologists and their patients entering the study had proven and criteria. Exclusion criteria: 1) age younger than 18 years old. 2) disease duration more than 5 years. 3) existence of any type of cancer. 4) pregnancy. Individuals with the inclusion criteria were randomly divided into two groups of 30. Study duration is almost 9 months.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016112530817N1
Registration date: 2017-01-07, 1395/10/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-07, 1395/10/18
Registrant information
Name
Mahak Ahmad Fakhrodin
Name of organization / entity
Jondi Shapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 3190
Email address
housmand.g@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondi Shapour University of Medical Sciences
Expected recruitment start date
2015-07-27, 1394/05/05
Expected recruitment end date
2016-04-24, 1395/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effects of anti-inflammatory capsules (containing three of ginger, turmeric and black pepper) in 60 patients with active rheumatoid arthritis according to DAS28 criteria
Public title
Study the effects of anti-inflammatory capsules (containing three of ginger, turmeric and black pepper) in patients with active rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age over 18 years old and people with rheumatoid arthritis. Exclusion criteria: age under 18 years old; disease duration more than 5 years; pregnancy; cancer.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
None
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahwaz Jondi Shapour University of Medical Sciences
Street address
Ahwaz Jondi Shapour University of Medical Sciences, Golestan
City
Ahwaz
Country
Iran (Islamic Republic of)
Postal code
Approval date
2015-08-10, 1394/05/19
Ethics committee reference number
IR.AJUMS.REC.1394.721

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
DAS28
Timepoint
The first blood before the onset of drug use to be. Then the end of 8 weeks, blood samples were taken at the end of the intervention.
Method of measurement
Through the blood

Secondary outcomes

1

Description
CRP
Timepoint
The first blood before the onset of drug use to be. Then the end of 8 weeks, blood samples were taken at the end of the intervention.
Method of measurement
Through the blood

Intervention groups

1

Description
The intervention group for 8 weeks receive anti-inflammatory capsules (containing three of ginger, turmeric and black pepper)2 times a day
Category
Treatment - Drugs

2

Description
The control group received placebo for 8 weeks to receive 2 times a day
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Dr Elham Rajaei
Street address
Golestan hospital
City
Ahwaz
Country
Iran (Islamic Republic of)

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice President of Research Jondishapour University of Medical Sciences
Full name of responsible person
Dr. Behzad Sharif Makhmalzadeh
Street address
Ahwaz Jondi Shapour University of Medical Sciences
City
Ahwaz
Country
Iran (Islamic Republic of)
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research Jondishapour University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahwaz Jondi Shapour University of Medical Sciences
Full name of responsible person
Dr Ali Asghar Hemmati
Position
Professor of Pharmacology PhD
Other areas of specialty/work
Street address
Ahwaz Jondi Shapour University of Medical Sciences, Golestan
City
Ahvaz
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 61 3373 8382
Fax
Email
hemmati-aa@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahwaz Jondi Shapour University of Medical Sciences
Full name of responsible person
Dr Ali Asghar Hemmati
Position
Professor of Pharmacology
Other areas of specialty/work
Street address
Ahwaz Jondi Shapour University of Medical Sciences, Golestan
City
Ahvaz
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 61 3373 8382
Fax
Email
hemmati-aa@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahwaz Jondi Shapour University of Medical Sciences
Full name of responsible person
Dr Mahak Ahmad Fakhrodin
Position
Pharmacist
Other areas of specialty/work
Street address
Ahwaz Jondi Shapour University of Medical Sciences, Golestan
City
Ahwaz
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 61 3373 8382
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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