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

An open controlled non-randomized clinical trial to study the clinical efficacy of the drug "Eryxin" produced by "Namangan Pharm Plant"

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13331870

Enrollment

Registered

2024-02-07

Start date

2024-02-05

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

Safety and efficacy in patients with rheumatoid arthritis Musculoskeletal Diseases

Interventions

Current interventions as of 19/03/2025: This study is an open-label non-randomized controlled trial. Participants will be divided into 2 groups. The first group will receive conventional therapy (me

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 11/04/2025: Tolerability will be assessed throughout the study (from the first use of the study drug) using the following data: 1. Adverse event report data 2. Physical examination data, vital signs (BP, HR, HRD, body temperature) 3. Pain will be measured using a visual analogue scale (VAS) on day 1 and day 30 4. Inflammation activity of rheumatoid arthritis will be measured using the Disease Activity Score-28 (DAS-28) index on day 1 and day 30 Previous primary outcome measure: Tolerability will be assessed throughout the study (from the first use of the study drug) using the following data: 1. Adverse event report data 2. Physical examination data, vital signs (BP, HR, HRD, body temperature) 3. Pain will be measured using a visual analogue scale (VAS) on day 1, day 10, and day 30 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	—

Measure

Time frame

Current primary outcome measure as of 11/04/2025: Tolerability will be assessed throughout the study (from the first use of the study drug) using the following data: 1. Adverse event report data 2. Physical examination data, vital signs (BP, HR, HRD, body temperature) 3. Pain will be measured using a visual analogue scale (VAS) on day 1 and day 30 4. Inflammation activity of rheumatoid arthritis will be measured using the Disease Activity Score-28 (DAS-28) index on day 1 and day 30 Previous primary outcome measure: Tolerability will be assessed throughout the study (from the first use of the study drug) using the following data: 1. Adverse event report data 2. Physical examination data, vital signs (BP, HR, HRD, body temperature) 3. Pain will be measured using a visual analogue scale (VAS) on day 1, day 10, and day 30 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

Measure	Time frame
Current secondary outcome measure as of 11/04/2025: 1. Immunological changes measured using flow cytometry (CD3, CD4, CD8 cells) and ELISA (IL-1, IL-6, TNF) at day 1 and day 30 Previous secondary outcome measure: 1. Immunological changes measured using flow cytometry (CD3, CD4, CD8 cells) and ELISA (IL-1, IL-6, TNF) at day 1, day 11-15, and day 30	—

Countries

Uzbekistan

Contacts

Public ContactUmid Akbarov

akbarov.umid@gmail.com+998903219229

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026