Chronic Joint Disease Caused by Chikungunya Virus
Conditions
Interventions
Group I (experimental): Homeostec (5 ml) + Paracetamol (500 mg). The patient will receive 5 ml de Homeostec intravenously (electrolyzed solution with neutro ph) diluted in 20 ml of salt solution (NaCl
Acetaminophen
Administration, Intravenous
Administration, Oral
Tablets
Homeostec,
Solución electrolizada,
Paracetamol
Sponsors
Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico
ESTERIPHARMA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with confirmed diagnosis of Chikungunya virus infection by RT-PCR or ELISA (IgG and / or IgM anti-Chikungunya) in the previous months. 2. Age: 18 years and older. 3. Persistent musculoskeletal pain or arthritis for more than 4 weeks after onset of Chikungunya virus infection. 4. Suffering musculoskeletal or joint pain maximum on analogue-visual scale of 4 or more in the last 24 hours 5. Acceptance in writing, previous information. 6. Negative urine pregnancy test.
Exclusion criteria
Exclusion criteria: 1. Rheumatoid arthritis. 2. Autoimmune diseases. 3. Symptomatic osteoarthritis prior to infection. 4. Decompensated systemic disease. 5. Creatinine 1.25 times greater than normal value or creatinine clearance less than 50 milliliters / minute (Cockfrot and Gault method). 6. Leukocytes equal to or less than 3000 cells / µL or platelet count less than 100,000 cells / µl. 7. Blood hemoglobin less than 10g / dL. 8. Increase in the last month of diastolic blood pressure to 110 mmHg or more and / or appearance of hematuria or proteinuria greater than 300 milligrams / day. 9. Pseudo intestinal obstruction. Defined as abdominal pain, with airway levels on AP and lateral lateral views of the abdomen. 10. Pregnant women or women of childbearing potential without a contraceptive method: salpingoclasia, device or hormonal, or Breastfeeding women. 11. Alcoholism and/or drug addiction. 12. Known liver disease with twice the increase in liver function tests (Aspartate amino transferase (AST), Alaninoamino transferase (ALT), alkaline phosphatase, bilirubin). 13. Presence of: Cancer. 14. Other pathologies at the discretion of the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events (Present, Absent. Adverse Events will be measured according to the Common Terminology Criteria for Adverse Events V3.0 (CTCAE). During the application of HOMEOSTEC the patient will have a cardiac monitor during 6 hours. Blood tests (pH, blood count, serum electrolytes, bleeding tests, and blood chemistry), physical examination and interrogation will be performed). Measuring time: at baseline, at 15 and 60 minutes, at 6, 24, 48 and 72 hours, at 15 and 30 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Joint pain (analogue-numeric scale of pain). Measuring time: at baseline, at 6, 24, 48 and 72 hours, at 15 and 30 days. Progression of joint disease (Routine Assessment of Patient Index Data-RAPID 3, >12 = High; between 6.1 and 12 Moderate; between 3.1 and 6 low; between 0 and 3 remission): Measuring time: at baseline, at 6, 24, 48 and 72 hours, at 15 and 30 days. | — |
Countries
Mexico
Contacts
Public ContactIvan Delgado Enciso
Cancerology State Institute, Colima State Health Service
Outcome results
None listed