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Clinical Trials/RPCEC00000249
RPCEC00000249
Not yet recruiting
Phase 2

EVALUATION OF HOMEOSTEC INTRAVENOUS APPLICATION IN PATIENTS WITH CHRONIC MANIFESTATIONS OF CHIKUNGUNYA VIRUS INFECTION: CLINICAL TRIAL PHASE II-III - CHIKCRONTX2

Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico0 sites50 target enrollmentAugust 15, 2017
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ConditionsChronic arthritis for ChikungunyaInfectionMusculoskeletal DiseasesJoint DiseasesChikungunya FeverArthritisArthritis, Infectious

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Chronic arthritis for Chikungunya
Sponsor
Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico
Enrollment
50
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 15, 2017
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

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

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

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