Arthritis following the acute phase of Chikungunya
Conditions
Interventions
Ozone Therapy Group (Experimental): Medical ozone in gaseous form will be administered rectally for 4 weeks, daily from Monday to Friday (20 sessions), using the ascending stepwise method as shown bel
Week 2: Concentration of 25 µg/mL in 150 mL of volume
Week 3: Concentration of 30 µg/mL in 200 mL of volume
and Week 4: Concentration of 25 µg/mL in 200 mL of volume.
Sponsors
National Center for Scientific Research (CNIC)
Ministry of Public Health (MINSAP), CUBA
Eligibility
Sex/Gender
All
Age
19 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Adults of any sex, older than 19 years until 90 years old. 2. Clinically confirmed diagnosis of Chikungunya. 3. Signed informed consent form agreeing to participate in the clinical trial. 4. Persistent joint pain (mild to moderate, as measured by the VAS) and swelling following Chikungunya.
Exclusion criteria
Exclusion criteria: 1. Glucose-6-phosphate dehydrogenase deficiency (favism). 2. Anemia (Hb = 10 g/L). 3. Pregnancy. 4. Thrombocytopenia. 5. Uncontrolled hypertension (SBP > 140 mmHg, DBP > 90 mmHg). 6. Hyperthyroidism. 7. Seizures. 8. Unstable heart disease. 9. Chronic diseases without evidence of beneficial use of ozone therapy. 10. Hypoglycemia. 11. Ozone allergy. 12. Alcoholism. 13. Cognitive impairment that prevents truthful answers. 14. Use of steroids or immunosuppressants. 15. Local inflammatory processes in the application area.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Joint pain (Using VAS (Visual Analog Scale) where 0-No pain, 1–3 Mild pain, 4–6 Moderate pain, and 7–10 Severe pain). Measurement time: At baseline, and for 4 weeks, on a weekly basis | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Joint Function (Measured using the HAQ (Health Assessment Questionnaire), which has values between 0 (no disability) and 3 (maximum disability)). Measurement period: At baseline, and for 4 weeks, on a weekly basis. 2. Disease Activity Score (DAS) (3.2–5.1 moderate disease activity, >5.1 high disease activity). Measurement time: At baseline and end of treatment. 3. Redox status (The following values will be measured: MDA (Malonaldehyde Concentration), PP (Lipid Peroxidation Susceptibility), CAT (Catalase Enzyme Activity), GSH (Reduced Glutathione Concentration), SOD (Superoxide Dismutase Enzyme Activity), PAOP (Advanced Protein Oxidation Products Concentration), HOP (Total Organoperoxide Concentration)). Measurement time: At baseline and end of treatment. 4. Quality of life (Measured using the EQ-5D 3L Questionnaire, where 5 indicates the best quality of life, and 15 indicates the Worst quality of life). (Worse quality of life). Measurement time: At baseline and end of treatment. 5. Adverse Events- AE (The following will be measured: Incidence of AE in patients (Yes, No); Description of the AE (Symptoms and/or signs); Date and time of start and stop; Severity of the AE (According to CTCAE severity grades 1 to 5); Causality of the AE (Very likely, likely, possible, unlikely, unrelated); Management: (No treatment required; General measures; Emergency treatment; Hospital admission); Outcome of the AE (Recovered, improved, persists, sequelae, death); Attitude towards treatment: (No change, dose modification, discontinuation)). Measurement time: At the end of the 4 weeks of treatment. 6. Hematological parameters (For hematological toxicity, Hemoglobin, Red blood cell count, White blood cell count, and Platelet count will be measured; for Liver function, Alanine will be measured. Aspartate aminotransferase (ALT) and aspartate aminotransferase (AST) will be measured; for pancreatic function, blood glucose will be measured, and for renal function, creatinine will be | — |
Countries
Cuba
Contacts
Public ContactEvelyn Gonzalez Pla
National Center for Scientific Research (CNIC)
Outcome results
None listed