The effects of garlic tablet on inflammatory biomarkers, serum total antioxidant capacity, serum malondialdehyde, fatigue, and clinical symptoms in patients with rheumatoid arthritis.
The effects of garlic tablet on inflammatory biomarkers, serum total antioxidant capacity, serum malondialdehyde, fatigue, and clinical symptoms in patients with rheumatoid arthritis
Design
Two arm parallel group randomized trial with blinded postoperative care and outcome assessment.
Settings and conduct
This double-blind randomized clinical trial will conduct on 70 eligible RA patients. Blocked randomization will run through Random Allocation
Software (RAS) to assign patients into two parallel groups (1:1) with four participants in each block.Patients in the intervention group will receive 500 mg garlic tablets twice a day and control group will receive placebo for 8 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diagnosis of rheumatoid arthritis by a physician based on criteria (ACR)
Having active disease
Intake of stable doses of corticosteroids during the past month
not inclusion criteria
suffering from diabetes mellitus, thyroid disorders, or kidney or hepatic diseases
allergy to garlic
using warfarin or other anticoagulants
Intervention groups
Patients in the intervention group will receive 500 mg garlic tablets twice
a day and control group will receive placebo.
Main outcome variables
The effects of garlic tablet on inflammatory biomarkers, serum total antioxidant capacity, serum malondialdehyde, fatigue, and clinical symptoms in patients with rheumatoid arthritis is assessed.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141108019853N6
Registration date:2019-10-01, 1398/07/09
Registration timing:prospective
Last update:2019-10-01, 1398/07/09
Update count:0
Registration date
2019-10-01, 1398/07/09
Registrant information
Name
Zamzam Paknahad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3166
Email address
paknahad@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-02, 1398/07/10
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of garlic tablet on inflammatory biomarkers, serum total antioxidant capacity, serum malondialdehyde, fatigue, and clinical symptoms in patients with rheumatoid arthritis.
Public title
The effects of garlic tablet in patients with rheumatoid arthritis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of rheumatoid arthritis by a physician based on criteria (ACR)
Having active disease
Intake of stable doses of corticosteroids during the past month.
Exclusion criteria:
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization will run through Random Allocation
Software (RAS) to assign patients into two parallel
groups (1:1) with four participants in each block.
Blinding (investigator's opinion)
Double blinded
Blinding description
none of the patients, as well as the researcher, clinical care, the outcome evaluator and data analyzer will be aware of the group in which the patients are allocated and the type of intervention received.
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
Hezar Jarib Street- Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-04-27, 1398/02/07
Ethics committee reference number
IR.MUI.MED.REC.1398.027
Health conditions studied
1
Description of health condition studied
rheumatoid arthritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis disease
Primary outcomes
1
Description
Mean difference of serum CRP.
Timepoint
Before and after intervention
Method of measurement
Serum level.
2
Description
Mean difference of serum TNFa .
Timepoint
Before and after intervention
Method of measurement
Serum level.
3
Description
Mean difference of serum TAC.
Timepoint
Before and after intervention
Method of measurement
Serum level
4
Description
Mean difference of serum MDA .
Timepoint
Before and after intervention
Method of measurement
Serum level
5
Description
Mean difference of ESR.
Timepoint
Before and after intervention
Method of measurement
Photo-metric
6
Description
Mean difference fatigue score in fatigue questionnaire
Timepoint
Before and after intervention
Method of measurement
Fatigue questionnaire
7
Description
Mean difference of clinical symptoms.
Timepoint
Before and after intervention
Method of measurement
DAS-28 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group receive 500 mg garlic tablets twice a day for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: control group receive placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Clinic in shiraz
Full name of responsible person
دکتر زهرا حبیب آگهی
Street address
Namāzī, Karim Khan Zand Blvd
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۷۱۴۷۳۷
Phone
+98 71 3612 1000
Email
zagahi@sums.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
Deputy of Research & Technology of Isfahan University of Medical Sciences-Hezar Jarib Street,isfahan,iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
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
Dr. Zamzam Paknahd
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3166
Email
paknahad@hlth.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Zamazam Paknahad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3166
Email
paknahad@hlth.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Zamzam Paknahd
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 2784
Email
paknahad@hlth.mui.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