Objectives: This study conducted to evaluate the effect of ginger powder on NF-KB, Ox-LDL, lipid profile and clinical symptoms in Rheumatoid arthritis patients.
Design: A randomized, double-blind, placebo-controlled clinical trial was conducted on 72 rheumatoid arthritis referred to rheumatologic clinic of Urmia Emam KHomeini hospital Setting and conduct: Patients were divided randomly into 2 groups, intervention group (receiving ginger tablet 1.5 gr/day) and placebo group (placebo tablet 1.5 gr/day) for 8 weeks.
Participants: inclusion criteria were rheumatoid arthritis patients with aged 25-75 years old. Exclusion criteria including: pregnancy and breastfeeding; mellitus diabetes; thyroid and kidney disorders; smoking; infectors myocardial; hyperthyroidism; NF-KB, Ox-LDL, ESR Lipid profile (HDL-C, LDL-C, TC, TG) and clinical symptoms before and after 8 weeks intervention were compared between two groups. The DAS-28 questionnaire to evaluate the clinical symptoms and 24-hour dietary recalls was filled for participants in before and after the intervention duration.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016083129508N2
Registration date:2016-10-08, 1395/07/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-08, 1395/07/17
Registrant information
Name
Rasoul Zarrin
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9935
Email address
rasoul.zarrin@uqconnect.edu.au
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences
Expected recruitment start date
2015-02-25, 1393/12/06
Expected recruitment end date
2015-05-28, 1394/03/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of ginger powder on NF-KB, Ox-LDL, lipid profile and clinical symptoms in Rheumatoid arthritis patients
Public title
Investigation the effect of ginger powder on NF-KB, Ox-LDL, lipid profile and clinical symptoms in Rheumatoid arthritis patients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion Criteria: rheumatoid arthritis patients; age group 25-75 years. Exclusion Criteria including: pregnancy and breastfeeding; mellitus diabetes; thyroid and kidney disorders; smoking; infectors myocardial; hyperthyroidism; NF-KB, Ox-LDL, Lipid profile and clinical symptoms before and after intervention were compared between two groups.
Age
From 25 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
72
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
Ethics committee, Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat Ave, Jahad street, Urmia
City
Urmia
Postal code
Approval date
2015-02-24, 1393/12/05
Ethics committee reference number
IR.umsu.REC.1393.289
Health conditions studied
1
Description of health condition studied
rheumatoid arthritis
ICD-10 code
M05.0
ICD-10 code description
Rheumatoid arthritis with splenoadenomegaly and leukopenia
Primary outcomes
1
Description
number of swollen joint
Timepoint
before intervention, 8 weeks after intervention
Method of measurement
The clinical diagnosis
2
Description
NF-KB
Timepoint
before intervention, 8 weeks after intervention
Method of measurement
Ng/ml
3
Description
OxLDL
Timepoint
before intervention, 8 weeks after intervention
Method of measurement
Ng/L
4
Description
HDL-C
Timepoint
before intervention, 8 weeks after intervention
Method of measurement
mg/dl
5
Description
LDL-C
Timepoint
before intervention, 8 weeks after intervention
Method of measurement
mg/dl
6
Description
TC
Timepoint
before intervention, 8 weeks after intervention
Method of measurement
mg/dl
7
Description
TG
Timepoint
before intervention, 8 weeks after intervention
Method of measurement
mg/dl
8
Description
ESR
Timepoint
before intervention, 8 weeks after intervention
Method of measurement
Ml/hr
9
Description
RF
Timepoint
before intervention, 8 weeks after intervention
Method of measurement
-/+
Secondary outcomes
1
Description
Pain
Timepoint
before intervention, 3 months after intervention
Method of measurement
according visual analog scale
Intervention groups
1
Description
intervention group: receiving ginger tablet 1.5 gr/day for 8 weeks
Category
Other
2
Description
placebo group: placebo tablet 1.5 gr/day) for 8 weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology clinic of Urmia Emam Khomeini Hospital
Full name of responsible person
Dr. Rasoul Zarrin
Street address
Department of nutrition, Medicine Faculty, Nazlou Pardis , 11th km of Nazlou Road, Urmia, Iran
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Urmia University of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebbi
Street address
Urmia University of Medical Sciences, Jahad Street, Resalat Ave, Urmia
City
Urmia
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, Urmia 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
Urmia University of Medical Sciences
Full name of responsible person
Dr. Rasoul Zarrin
Position
Assistant Professor of Nutrition
Other areas of specialty/work
Street address
Department of Nutrition, Medicine Faculty, Nazlou Pardis , 11th km of Nazlou Road, Urmia, Iran