Homeostec for chronic arthritis

Phase 2

Conditions: Chikungunya Fever
Arthritis
Chronic arthritis for Chikungunya
Infection
Musculoskeletal Diseases
Arthritis, Infectious
Joint Diseases

Registration Number: RPCEC00000249

Lead Sponsor: Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 50

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Joint pain (analogue-numeric scale of pain). Measurement time: baseline, at 15 and 30, 60, 90, 120 and 180 days.<br>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 Outcome Measures

Name	Time	Method
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.