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Comparing the effect of edible olibanum, and curcumin on blood and inflamatory factors in rheumatoid arthritis patients

Protocol summary

Summary
Objectives: Survey and compare effect of Olibanum and Curcumin supplementation on blood and inflammatory factors in rheumatoid arthritis patients Design: Double blind Clinical trial Procedure: Ninety patients with rheumatoid arthritis will be enrolled and divided randomly based on random numbers tables into three groups (Olibanum and Curcumin) and placebo. Blinding will be done for patients and researchers. Inclusion criteria: Diagnosis of rheumatoid arthritis specialist according 1987 ACR (ACR); Lack of pregnancy and lactation Exclusion criteria: Diseases that require special treatment and the intervention disrupts (such as accidents, trauma or exacerbation for reasons such as extreme stress); alcoholic; allergic to Olibanum and curcumin Intervention: The first group for three months, three capsules of 500 mg per day, and to the second group, 3 capsules of curcumin 40, and to the third group (control), 3 capsules of 500 mg of placebo were given in terms of apparent characteristics, which are quite similar to the intervention material. The main outcome variables: Blood tests including cholesterol, triglyceride, HDL, LDL, TFN-alpha and HS-CRP, antioxidant, fasting blood sugar and insulin factors before and after the intervention will be measured

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017011614925N2
Registration date: 2017-11-07, 1396/08/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-07, 1396/08/16
Registrant information
Name
Maryam Javadi
Name of organization / entity
Qazvin University of Medical Sciences, Department of Health
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 5367
Email address
mjavadi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2017-03-20, 1395/12/30
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Comparing the effect of edible olibanum, and curcumin on blood and inflamatory factors in rheumatoid arthritis patients
Public title
Comparing the effect of edible olibanum, and curcumin on blood and inflamatory factors in rheumatoid arthritis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Willing to participate in study; Clinical diagnosis of rheumatoid arthritis (meeting the American college of rheumatology 1987 criteria); No smoking or addiction; No drug type and dose fluctuation since 1 month prior to the study and during intervention period ; Not having severe cardiovascular; Hepatic; Kidney; Gastrointestinal; Thyroid; Parathyroid diseases; Diabetes and inflammation; Not using medications except for AR conventional drugs; No pregnancy or lactation Exclusion criteria: Developing illnesses which need particular cures or interfere with intervention such as increasing the disease activity or trauma; alcoholic; sensitivity to olibanum and turmeric
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Qazvin, Shahid Bahonar Blvd., Qazvin University of Medical Sciences
City
Qazvin
Postal code
3419759811
Approval date
2017-05-13, 1396/02/23
Ethics committee reference number
IR.QUMS.REC.1396.117

Health conditions studied

1

Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M05
ICD-10 code description
Seropositive rheumatoid arthritis

Primary outcomes

1

Description
Hs- CRP
Timepoint
Befor intervention, End of the intervention
Method of measurement
ELISA

2

Description
Blood lipid
Timepoint
Befor intervention, End of the intervention
Method of measurement
Laboratory

3

Description
Fasting insulin
Timepoint
Befor intervention, End of the intervention
Method of measurement
HOMA-IR

Secondary outcomes

1

Description
Serum levels of Total Antioxidant Capacity
Timepoint
Befor intervention, End of the intervention
Method of measurement
Laboratory ELISA

2

Description
Rheumatoid factor
Timepoint
Befor intervention, End of the intervention
Method of measurement
Laboratory

Intervention groups

1

Description
Second intervention group: Three capsules of 500 mg olibanum, Daily, for 3 months
Category
Treatment - Drugs

2

Description
First intervention group 1: Three capsules of Nano curcumin 40 mg, daily for 3 months
Category
Treatment - Drugs

3

Description
Control group: Three 500 mg capsol of wheat flour daily, for 3 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Rheumatology Clinic of Qazvin University of Medical Sciences
Full name of responsible person
Dr mahnaz Abasi
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Ave., Qazvin, Iran
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin University of Medical Sciences
Full name of responsible person
Dr. Peymani
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Ave., Qazvin, Iran
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Maryam Javadi
Position
Associate Professor, Ph.D. in Nutrition
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Ave., Qazvin, Iran
City
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6005
Fax
Email
mjavadi@qums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University in Medical Sciences
Full name of responsible person
Dr. Maryam Javadi
Position
Ph.D. in Nutrition, Associate Professor
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Ave., Qazvin, Iran
City
Qazvin
Postal code
3419759811
Phone
+98 283336005
Fax
Email
mjavadi@qums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Maryam Javadi
Position
Associate Professor, Ph.D. in Nutrition
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Ave., Qazvin, Iran
City
Qazvin
Postal code
3419759811
Phone
+98 283336005
Fax
Email
mjavadi@qums.ac.ir
Web page address

Sharing plan

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