Comparing the effects of α-L-Guluronic acid with conventional Non-steroidal anti-inflammatory drugs on disease activity and inflammatory markers in patients with ankylosing spondylitis
The aim of this study is to assess the safety and effectiveness of α-L-Guluronic acid in patients with Ankylosing spondylitis. α-L-Guluronic acid has shown therapeutic effects with the greatest tolerability and safety in various experimental models such as experimental autoimmune encephalitis, adjuvant induced arthritis, nephrotic syndrome and acute glomerulonephritis. In this randomized, controlled trial, thirty five patients with Ankylosing spondylitis fulfilling the modified New York criteria that have active disease (BASDAI score ≥ 4 and BASFI score ≥ 4) will be examined. Additionally, patients do not have other concomitant diseases (Hepatic, renal and cardiovascular) or malignancies. Written informed consent will be obtained. Patients will be randomly assigned to receive either α-L-Guluronic acid (treatment group, 25 patients) 1500 mg/day (three 500 mg tablets/day) or conventional Non-steroidal anti-inflammatory drugs (control group, 10 patients) orally for 12 weeks. Medical history, physical examinations, BASDAI and BASFI scores, serum level of CRP and level of ESR will be evaluated at baseline and 12 weeks after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091813739N4
Registration date:2016-10-10, 1395/07/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-10-10, 1395/07/19
Registrant information
Name
Abbas Mirshafiey
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 4913
Email address
mirshafiey@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2016-11-05, 1395/08/15
Expected recruitment end date
2017-03-18, 1395/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of α-L-Guluronic acid with conventional Non-steroidal anti-inflammatory drugs on disease activity and inflammatory markers in patients with ankylosing spondylitis
Public title
The therapeutic effects of α-L-Guluronic acid in patients with ankylosing spondylitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients aged 18-45 years old; Diagnosis of "Definite AS" as defined by the modified New York criteria; Disease activity equal to BASDAI score ≥ 4; Functional activity equal to BASFI score ≥ 4; Each patient must sign written informed consent.
Exclusion Criteria: History of fever and Infectious diseases; Positive pregnancy test or Lactation; Other collagen - vascular diseases; Other auto-immune diseases; Malignancies; Patients have enrolled another clinical trial study within last 4 weeks; Other concomitant diseases (Hepatic, renal, hematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease).
Age
From 18 years old to 45 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
25
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 of Tehran University of Medical Sciences
Street address
6th floor, Headquarter for Tehran University of Medical Sciences, On the Corner of Keshavarz Blvd, and Qods Street, Keshavarz Blvd., Tehran, Iran
City
Tehran
Postal code
Approval date
2016-09-14, 1395/06/24
Ethics committee reference number
IR.TUMS.VCR.REC.1395.621
Health conditions studied
1
Description of health condition studied
Ankylosing spondylitis
ICD-10 code
M45
ICD-10 code description
Ankylosing spondylitis
Primary outcomes
1
Description
The ASAS20 response criteria
Timepoint
12 weeks after intervention (at the end of study)
Method of measurement
Questionnaire
2
Description
Disease activity
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Questionnaire
3
Description
Physical function
Timepoint
At baseline and after 12 weeks of treatment.
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Serum level of CRP
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Turbidometry
2
Description
level of ٍُESR
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Observing with Westegren method
Intervention groups
1
Description
Intervention group will receive 1500 mg/day (three 500 mg tablets/day) of α-L-Guluronic acid orally for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group will receive 1500 mg/day (three 500 mg tablets/day) of plcebo orally for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology research center, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mahdi Mahmoudi (PhD- Assistant Professor)
Street address
Rheumatology research center, Dr.Shariati Hospital, Jalal-e-Al-e-Ahmad St, North Kargar St, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Masood Younesian (MD, PhD, Vice-Chancellor for Research, Tehran University of Medical Sciences)
Street address
6th floor, Headquarter for Tehran University of Medical Sciences, On the Corner of Keshavarz Blvd. and Qods Street, Keshavarz Blvd., Tehran, Iran
City
Tehran
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, Tehran 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
Department of pathobiology, School of Public Health, Tehran University of Medical Sciences
Full name of responsible person
Dr. Abbas Mirshafiey
Position
Head of the Department of pathobiology (PHD - Professor)
Other areas of specialty/work
Street address
Department of pathobiology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8895 4913
Fax
Email
mirshafiey@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of pathobiology, School of Public Health, Tehran University of Medical Sciences
Full name of responsible person
Dr. Abbas Mirshafiey
Position
Head of the Department of pathobiology (PhD - Professor)
Other areas of specialty/work
Street address
Department of pathobiology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8895 4913
Fax
Email
mirshafiey@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)