跳至主要内容
临床试验/CTRI/2018/07/014988
CTRI/2018/07/014988已完成4 期

A Multi-centric, Double blind, Placebo controlled, Randomized, observational study to evaluate the Efficacy and Safety of Carica Papaya Leaf Extract, (ZYBORICA TABLET ) as empirical therapy for thrombocytopenia associated with dengue fever

Mi Lab LifeSciencesP Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
发起方

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

  • 1.Male and female patients above 18 years and below 60 years old,
  • 2.Patients who are confirmed to have DF or DHF grade I and II by NS1 antigen test,
  • 3.Patients having thrombocytopenia with at platelet count between 30,000 /micro litre to 150,000/micro litre,
  • 4.Patients with a baseline alanine transaminase (ALT) level of not more than 3 times of the upper limit of the normal range (not more than 165â??U/L),
  • 5.Patient who is willing to give informed consent to participate in study

排除标准

  • 1.Patients with Dengue hemorrhagic fever grade III and IV,
  • 2.Patients with platelet count less than 30,000/micro litre,
  • 3.Pregnant or lactating women,
  • 4.Patients who have received blood or blood products transfusion during the current illness,
  • 5.Patients with thrombocytopenia Purpura (ITP), Leukemia, Hemophilia,
  • 6.Patients who have a serum ALT level 3 times higher than the upper limit of the normal range ( >165â??U/L),
  • 7.Impaired renal function with serum creatinine >1.5 mg/dl(males) and >1.4 mg/dl(females)
  • 8.Participation in another trial with an investigational drug within 1 month prior to this trial.
  • 9. Hypersensitivity to any of the components of the formulation,
  • 10.The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in this clinical study.

研究者

发起方
Mi Lab LifeSciencesP Limited

相似试验