The therapeutic effects of a-L-Guluronic acid in patients with Rheumatoid Arthritis

Conditions

Rheumatoid Arthritis. Seropositive Rheumatoid Arthritis

Tahereh Bakhtiari, ShahinKhadem Azarian, Afshin Ghaderi, Arman Ahmadzadeh, Abbas Mirshafiey

Iranian Journal of Allergy Asthma and Immunology2020-01-078 citations

10.18502/ijaai.v18i6.2176

Effects of guluronic acid, as a new NSAID with immunomodulatory properties on IL-17, RORγt, IL-4 and GATA-3 gene expression in rheumatoid arthritis patients

Shahin Khadem Azarian, Fahimeh Jafarnezhad‐Ansariha, Sepideh Nazeri, Gholamreza Azizi, Zahra Aghazadeh et al. (7 authors)

Immunopharmacology and Immunotoxicology2019-12-1912 citations

10.1080/08923973.2019.1702053

A randomized clinical trial for the assessment of the efficacy and safety of guluronic acid (G2013) in patients with rheumatoid arthritis

Shahin Khadem Azarian, Maassoumeh Akhlaghi, Mahdi Mahmoudi, Shayan Mostafaei, Ahmadreza Jamshidi et al. (7 authors)

Immunopharmacology and Immunotoxicology2019-01-0211 citations

10.1080/08923973.2018.1555844

Interventions

Intervention 1: The intervention group will receive 1500 mg/day (three 500 mg tablets/day) of a-L-Guluronic acid orally for 12 weeks. The a-L-guluronic acid produced from the decomposition of Alginat

Treatment - Drugs

The intervention group will receive 1500 mg/day (three 500 mg tablets/day) of a-L-Guluronic acid orally for 12 weeks. The a-L-guluronic acid produced from the decomposition of Alginate powder (a saf

Control group will receive 1500 mg/day (three 500 mg tablets/day) of plcebo orally for 12 weeks.

Eligibility

Sex/Gender

All

Age

25 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 25-60 years old patients, Diagnosed with RA according to American College of Rheumatology Diagnostic Criteria after the initial visit by a specialist in rheumatology and parameters ESR, RF, CRP and Anti-CCP elected, 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
Morning stiffness. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Taking history and Questionnaire.;The number of swollen joints. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Examination.;Pain. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Examination.;Severity of disease. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Taking history and Questionnaire.	—

Measure

Time frame

Morning stiffness. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Taking history and Questionnaire.;The number of swollen joints. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Examination.;Pain. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Examination.;Severity of disease. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Taking history and Questionnaire.

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Secondary

Measure	Time frame
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: See through Westergren method.;Anti-cyclic Citrullinated Peptide (anti-CCP) Antibodies. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: ELISA.;Rheumatoid factor (RF). Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: See through Agglutination.	—

Measure

Time frame

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: See through Westergren method.;Anti-cyclic Citrullinated Peptide (anti-CCP) Antibodies. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: ELISA.;Rheumatoid factor (RF). Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: See through Agglutination.

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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