Chronic arthritis for Chikungunya
Conditions
Interventions
Group I. Homeostec (experimental): Homeostec (15 ml) + Paracetamol (500 mg). The patient will receive 15 ml of intravenous Homeostec (electrolyzed solution with neutral pH) diluted in 35 ml of 0.9% sa
Acetaminophen
Administration, Intravenous
Administration, Oral
Tablets
Homeostec,
Electrolyzed solution,
Paracetamol
Sponsors
Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico
Naval Hospital of Manzanillo of the Navy of 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 24hrs. 5. Acceptance in writing, prior information. 6. Women with contraceptive method with more than 90% efficacy and 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 onset 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 contraception: salpingoclasia, or hormonal devices. 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 investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Joint pain (analogue-numeric scale of pain). Measurement time: baseline, at 15 and 30, 60, 90, 120 and 180 days. Progression of joint disease (RAPID index 3> 12 = high, between 6.1 and 12 moderate, between 3.1 and 6 low, between 0 and 3 remission). Measurement time: baseline, at 15 and 30, 60, 90, 120 and 180 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events (Present, Absent. Adverse events will be categorized according to the "Common Terminology Criteria for Adverse Events" (CTCAE) version 3.). Measurement: baseline at 30, 60, 90 and 180 days. | — |
Countries
Mexico
Contacts
Public ContactIvan Delgado-Enciso
Cancerology State Institute, Colima State Health Service
Outcome results
None listed