The therapeutic effects of a-L-Guluronic acid in patients with ankylosing spondylitis

Phase 1

• Conditions: Ankylosing spondylitis.; Ankylosing spondylitis

• Registration Number: IRCT2016091813739N4
• Lead Sponsor: Vice-Chancellor for Research, Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 25

Inclusion 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).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The ASAS20 response criteria. Timepoint: 12 weeks after intervention (at the end of study). Method of measurement: Questionnaire.;Disease activity. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Questionnaire.;Physical function. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Serum level of CRP. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Turbidometry.;Level of ??ESR. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Observing with Westegren method.