SLCTR/2022/023尚未招募3 期
Double Blind Placebo Controlled Randomized Phase III trial to evaluate the efficacy of Eltrombopag to correct thrombocytopenia and prevent fluid leakage in moderate dengue patients
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •a.Age: More than 18 years and less than 65 years
- •b.Evidence of Dengue by Dengue NS1/Dengue IgM positive
- •c.Any one of the following warning signs:
- •abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation (not due to any other causes), evidenced by Ultrasound of the Chest and whole abdomen, mucosal bleeding, lethargy, liver enlargement >2 cm, rising of hematocrit (>20% of baseline) concurrent with a rapid decline in platelet.
- •(defined by National guideline 2019 )
- •d.Platelet count: below 1,00,000/mm3
排除标准
- •a.Known Pregnancy.
- •b.Patients with severe dengue (Category-3) and dengue shock syndrome
- •c.Abnormal liver function test.
- •d.SGPT >5 times of upper limit
- •e.Mild Dengue fever patient without warning signs (defined by National guideline 2019 )
- •f.Ascites due to another disease, eg- CLD, CKD, Disseminated TB, Malignancy.
- •g.Pleural Effusion due to other causes, eg- TB, Malignancy, CLD, CKD.
- •h.Thrombocytopenia caused by other factor such as Severe Aplastic Anemia (SAA), Chronic Liver Disease (CLD), and Immune- thrombocytopenia (ITP).
- •i.History of portal vein thrombosis.
- •j.Patients infected with HCV, HBV, chronic liver disease (Drug-induced, alcohol-induced).
- •k.Patients with any history of receiving immunosuppressive therapy.
- •l.Patients with any severe comorbidity.
研究者
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