RPCEC00000249尚未招募2 期

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 个研究点目标入组 50 人开始时间: 2017年8月15日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Single Blind. Control group: Active. Assignment: Parallel. Purpose: Treatment

•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.

•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.

发起方

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