A double blind clinical trial on the effect of saffaron tablet on changing level of inflammatory markers Interleukin 1 beta(IL1β) and Tumor necrosis factor alpha(TNFα) in patients with Knee osteoarthritis
The aim of this study was the evaluation of the effect of saffron on the serum levels of inflammatory markers and Knee osteoarthritis disease severity. 80 patients were enrolled to this study with knee osteoarthritis based on ACR criteria with an intensity of 2 to 3 KL radiography grade after obtaining consent.They should have no past history of rheumatologic disease, corticosteroid use, recent trauma within 6 months and chronic kidney disease with a GFR less than 30 ml/min/1.73m2.40 patients were treated with daily 100 mg saffron tablet(active constituents crocin) as intervention group and 40 patients were treated with daily placebo tablet(false color material and starch) as control group, these two groups were studied as double blind, randomized and parallel.At first, WOMAC questionnaire were filled to evaluate the severity of osteoarthritis and blood sample were obtained from patients for studying serum levels of IL 1 beta and TNF alpha, WOMAC questionnaire were filled again to evaluate the severity of osteoarthritis patients in week 6 and 12(at the end of intervention).Blood samples also were taken of all patients for evaluating level of inflammatory markers at the end of week 12.During study, patients were questioned based on the number of NSAID consumption and visual pain scale by respective collegian per week. Primary outcome of the study were the serum levels of TNF alpha, IL 1 beta and secondary outcome were the severity of osteoarthritis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091029777N1
Registration date:2017-03-13, 1395/12/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-13, 1395/12/23
Registrant information
Name
Mona Firouzabadi
Name of organization / entity
Golsestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3242 4377
Email address
firouzabadi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Science
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A double blind clinical trial on the effect of saffaron tablet on changing level of inflammatory markers Interleukin 1 beta(IL1β) and Tumor necrosis factor alpha(TNFα) in patients with Knee osteoarthritis
Public title
The effect of saffaron tablet on the level of inflammatory markers with knee osteoarthritis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Knee osteoarthritis patients based on American College of Rheumatology(ACR) diagnostic criteria with an intensity of 2 to 3 according to Kellgren and Lawrence(KL) radiography grade, Patients with an average age of 50 to 70 years old;
Exclusion criteria: Known hypersensitivity to Saffron, Patients with other rheumatologic diseases, Patients with active malignant disease or infection, Patients with known mental illness, Patients with a history of recent Knee surgery and severe trauma(within 6 months), Patients with hip osteoarthritis, Patients with septic arthritis, Patients with active gastrointestinal bleeding or a history of it, Patients with chronic kidney disease when the estimated Glomerular Filtration Rate(GFR) is less than 30 ml/min/1.73m2, Severe leukopenia, Patients requiring long term use of corticosteroids such as asthma or inflammatory bowel disease.
Age
From 50 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization will be done using the enclosed envelope.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Golestan University of Medical Science
Street address
4 Kilometer of Gorgan-sari Road, Falsafi educational campus, Vice Chancellor of Technology and Information, Gorgan
City
Gorgan
Postal code
4934174515
Approval date
2016-05-15, 1395/02/26
Ethics committee reference number
IR.GOUMS.REC.1395.22
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17.0
ICD-10 code description
Bilateral primary osteoarthritis of knee
Primary outcomes
1
Description
Serum levels of TNF alpha
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
pg/ml
2
Description
Serum levels of IL 1 beta
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
pg/ml
Secondary outcomes
1
Description
The intensity of osteoarthritis
Timepoint
Baseline and sixth and twelfth weeks
Method of measurement
WOMAC questionnaire
Intervention groups
1
Description
Intervention group: Including daily intake of 100 mg saffron(active constituents crocin) pill for 12 weeks
Category
Treatment - Drugs
2
Description
Control group:Including daily intake of 100 mg placebo saffron(false color material and starch) for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dezyani Specialty and subspecialty clinics
Full name of responsible person
Nafiseh Abdollahi
Street address
Dezyani Specialty and subspecialty clinics, Beheshti street, Gorgan
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Golestan University of Medical Sciences
Full name of responsible person
Mohsen Saeedi
Street address
4 Kilometer of Gorgan-sari Road, Falsafi educational campus, Vice Chancellor of Technology and Information, Gorgan
City
Gorgan
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, Golestan 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
Golestan University of Medical Science
Full name of responsible person
Mohsen Saeedi
Position
Research and Technolgy Managment
Other areas of specialty/work
Street address
4 Kilometer of Gorgan-sari Road, Falsafi educational campus, Vice Chancellor of Technology and Information, Gorgan
City
Gorgan
Postal code
Phone
+98 17 3242 4377
Fax
Email
Saeedi.M50@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Science
Full name of responsible person
Nafiseh Abdollahi
Position
Professor Rheumatology
Other areas of specialty/work
Street address
4 Kilometer of Gorgan-sari Road, Falsafi educational campus, Vice Chancellor of Technology and Information, Gorgan