The therapeutic effects of ß-D-Mannuronic acid in patients with ankylosing spondylitis

A randomized controlled trial comparing the effects of ß-D-Mannuronic acid and conventional Non-steroidal anti-inflammatory drugs on disease activity and inflammatory markers in patients with ankylosing spondylitis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013062213739N1

Enrollment

Registered

2013-12-30

Start date

2014-04-20

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing spondylitis. Ankylosing spondylitis

Interventions

Intervention 1: Treatment group will receive 1500 mg/day (three 500 mg tablets/day) of ß-D mannuronic acid orally for 12 weeks. Intervention 2: Control group will receive conventional Non-steroidal an

Treatment - Drugs

Treatment group will receive 1500 mg/day (three 500 mg tablets/day) of ß-D mannuronic acid orally for 12 weeks.

Control group will receive conventional Non-steroidal anti-inflammatory drugs orally for 12 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Patients age 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, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Serum level of CRP. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Turbidometry.;The frequency of circulating Th17 cells. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: flow cytometry.;The frequency of circulating regulatory T (Treg) cells. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: flow cytometry.;L- selectin expression. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: flow cytometry.;LFA-1 expression. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Real-time PCR.;Serum level of IL-6. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Elisa.;Serum level of IL-10. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Elisa.;Serum level of IL-17A. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Elisa.;Serum level of TNF-a. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Elisa.	—

Measure

Time frame

Serum level of CRP. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Turbidometry.;The frequency of circulating Th17 cells. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: flow cytometry.;The frequency of circulating regulatory T (Treg) cells. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: flow cytometry.;L- selectin expression. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: flow cytometry.;LFA-1 expression. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Real-time PCR.;Serum level of IL-6. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Elisa.;Serum level of IL-10. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Elisa.;Serum level of IL-17A. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Elisa.;Serum level of TNF-a. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Elisa.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Abbas Mirshafiey

Department of pathobiology, School of Public Health, Tehran University of Medical Sciences

mirshafiey@tums.ac.ir+98 21 8895 4913

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 9, 2026