A study of the safety and efficacy of Eryxin in patients with rheumatoid arthritis

Phase 1

Conditions: Safety and efficacy in patients with rheumatoid arthritis
Musculoskeletal Diseases

Registration Number: ISRCTN13331870

Lead Sponsor: amangan Pharm Plant LTD

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 60

Inclusion Criteria

1. Adults aged 18 years old and over
2. Written informed consent to participate in the study
3. With rheumatoid arthritis

Exclusion Criteria

1. Pregnancy
2. Lactation
3. Children aged under 18 years old
4. Presence of hypersensitivity to the drug components
5. Patient's participation in other clinical trials within the last 30 days
6. Absence of informed written consent of the patient to participate in a clinical trial
7. Hypersensitivity to the drug
8. Genetically determined glucose-6-phosphate dehydrogenase deficiency (risk of hemolytic anemia)
9. History of gastrointestinal bleeding or perforation associated with NSAID therapy
10. Active peptic ulcer/bleeding or a history of recurrent peptic ulcer/bleeding (two or more cases of confirmed ulcer or bleeding)
11. Hypersensitivity reactions (symptoms of asthma, rhinitis, angioedema, or urticaria) to other NSAIDs, including aspirin
12. Severe liver dysfunction
13. Severe impairment of renal function
14. Chronic heart failure in decompensation stage

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tolerability will be assessed throughout the study (from the first use of the study drug) using the following data:<br>1. Adverse event report data<br>2. Physical examination data, vital signs (BP, HR, HRD, body temperature)<br>3. Pain will be measured using a visual analogue scale (VAS) on day 1, day 10, and day 30<br>4. Inflammation activity of rheumatoid arthritis will be measured using the Disease Activity Score-28 (DAS-28) index on day 1, day 10 and day 30

Secondary Outcome Measures